Systems and methods for surgical and interventional planning, support, post-operative follow-up, and functional recovery tracking

ABSTRACT

Various systems and methods are provided for surgical and interventional planning, support, post-operative follow-up, and functional recovery tracking. In general, a patient can be tracked throughout medical treatment including through initial onset of symptoms, diagnosis, non-surgical treatment, surgical treatment, and recovery from the surgical treatment. In one embodiment, a patient and one or more medical professionals involved with treating the patient can electronically access a comprehensive treatment planning, support, and review system. The system can provide recommendations regarding diagnosis, non-surgical treatment, surgical treatment, and recovery from the surgical treatment based on data gathered from the patient and the medical professional(s). The system can manage the tracking of multiple patients, thereby allowing for data comparison between similar aspects of medical treatments and for learning over time through continual data gathering, analysis, and assimilation to decision-making algorithms.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. patent application Ser.No. 14/734,359 entitled “Systems And Methods For Surgical AndInterventional Planning, Support, Post-Operative Follow-Up, And,Functional Recovery Tracking” filed Jun. 9, 2015, which claims priorityto U.S. patent application Ser. No. 14/031,761 entitled “Systems AndMethods For Surgical And Interventional Planning, Support,Post-Operative Follow-Up, And, Functional Recovery Tracking” filed Sep.19, 2013, which claims priority to U.S. patent application Ser. No.13/803,763 entitled “Systems And Methods For Surgical And InterventionalPlanning, Support, Post-Operative Follow-Up, And Functional RecoveryTracking” filed Mar. 14, 2013, which claims priority to U.S. ProvisionalPatent Application No. 61/702,073 entitled “Systems And Methods ForSurgical Planning, Support, And Review” filed Sep. 17, 2012 and to U.S.Provisional Patent Application No. 61/739,514 entitled “Systems AndMethods For Surgical Planning, Support, And Review” filed Dec. 19, 2012,which are hereby incorporated by reference in their entireties.

FIELD

The present disclosure relates generally to systems and methods forsurgical and interventional planning, support, post-operative follow-up,and functional recovery tracking. More particularly, the presentdisclosure relates to planning, supporting, and reviewing surgeries thatinvolve medical devices, e.g., medical implants and instruments.

BACKGROUND

A traditional model for planning surgeries that involve medical devicesincludes several phases. These phases typically include wellness andprevention, diagnosis, and treatment.

The wellness and prevention phase typically involves a patient amonitoring their own health and having periodic check-up visits with aphysician. The diagnosis phase typically involves the physiciandetermining an ailment of the patient when the physician determines thatthe patient has a health problem. The physician can reach the diagnosisby consulting any one or more knowledge sources, such as their previousexperience and knowledge, consultation with colleague(s), review ofprint and/or electronic literature, and review of diagnostictests/procedures.

During the treatment phase, the physician typically determines atreatment plan for the patient to address the diagnosis, e.g., torelieve the patient of symptom(s). The treatment plan for many types ofmusculoskeletal and neurological diagnoses, for example, typicallybegins with a conservative, non-surgical treatment involving one or moretherapies such as diet modification, exercise, medication, rest, limbelevation, limb mobilization, physical therapy, chiropractic care, etc.If the conservative, non-surgical treatment fails to adequately addressthe diagnosis, e.g., fails to adequately remedy the patient'ssymptom(s), or if the physician determines that the patient's conditionis such that an approach more aggressive than a conservative,non-surgical treatment is needed to achieve desired results, thephysician typically modifies the treatment plan to include a lessconservative treatment. For diagnoses involving joint and/or boneailments, e.g., spine ailments such as scoliosis, shoulder ailments suchas injured rotator cuffs, knee ailments such as injured ACLs, etc., theless conservative treatment typically includes at least one invasiveprocedure such as injection therapy or a surgical procedure. Determiningwhich surgical procedure to perform on the patient and determining whichsurgical techniques and medical devices to use in the selected surgicalprocedure typically involves a significant amount of time and planningby at least the performing surgeon.

Planning each surgical procedure also logistically typically involvescoordination of numerous hospital resources. This planning alsotypically involves coordination with the patient for outpatientpreparation and testing. A traditional model for supporting and managingsurgeries that involve medical devices includes several phases. Thesephases typically include surgical planning, inventory planning,intra-operative support, post-surgery logistics, and charge capture orbilling.

During the surgical planning phase, a surgeon or a staff member at thesurgeon's office contacts the hospital where the surgery is to beperformed to schedule resources such as operating rooms, equipment, andsupport staff. The hospital maintains a surgery schedule using aspreadsheet, whiteboard, or internal enterprise resource planning systemthat includes information such as the type of surgery, the name of thesurgeon, the date the surgery is to be performed, and the supply andequipment needs of the surgery. A representative of a medical devicecompany obtains the surgery schedule periodically and, for each surgerythat involves a medical device provided by the medical device company,meets with the surgeon to discuss a plan for the surgery.

After establishing a plan for the surgery, the representative orders thevarious medical devices believed to be necessary for the surgery in theinventory planning phase. The medical devices are shipped from themedical device company or a distributor affiliated therewith to therepresentative, who is then responsible for providing the medicaldevices to the hospital for sterilization in advance of the surgery.

Prior to the surgery, the representative is typically relied upon toprovide pre-surgery training on any new or modified medical devices orinstruments. Such training can include use of hands-on demonstrationequipment or review of surgical brochures provided by the medical devicemanufacturer. The representative is generally responsible for selectingand executing the appropriate training, based on the availablesupporting materials.

During the surgery itself, the representative is typically present inthe operating room, regardless of the complexity of the surgery, toprovide technical support to the surgeon and staff. The representativeis also present to track consumption of inventory as well as componentsin need of maintenance or replacement.

After the surgery, the representative ensures that consumed inventory isreplenished and that reusable instruments are sterilized and preparedfor subsequent use.

Finally, the representative assists hospital staff in completingpaperwork that identifies the patient and the inventory consumed. Apurchasing group at the hospital reviews the paperwork and transmits itto the medical device company or its distributor. A manualreconciliation process occurs thereafter to determine billing amountsand to trigger inventory replenishment.

There are a number of inefficiencies associated with existing surgeryplanning, support, and management models. For example, by the time apatient consults a physician regarding self-detected symptom(s), thepatient may have difficulty remembering the exact timing and/orintensity of symptom progression over a period of days, weeks, ormonths, which can adversely affect a physician's ability to accuratelydiagnosis a problem and/or determine the necessary aggressiveness oftreatment.

For another example, during treatment, it can be difficult for aphysician to monitor the patient's progress and compliance with thetreatment, particularly during non-surgical treatment in which thepatient is not under direct medical care, e.g., in a hospital, atphysical therapy, etc, and more particularly when the patient is notunder daily supervision of medical care. Additionally, the patient mayprovide inaccurate treatment progress information to the physician, suchas by forgetting the exact timing of treatments performed at home or bybeing embarrassed to reveal failures in maintaining the suggestedtreatment and therefore not providing the physician with completelyaccurate information, and/or the patient may accidentally not perform arecommended treatment as instructed, such as by improperly performing anexercise, misunderstanding diet requirements, by forgetting to takemedication at a recommended time, etc. The physician may therefore havedifficulty determining whether and how to modify the patient's treatmentplan, which can delay and/or hinder the patient's healing.

For example, during planning of a surgical procedure, a surgeon istypically more likely to perform a familiar, previously-performedprocedures and use familiar, previously-used medical devices, e.g., toincrease the surgeon's comfort and confidence in performing the surgeryand to decrease the amount of time necessary to prepare for the surgery.However, the patient may thus not benefit from newer, improved surgicaltechniques and medical devices and/or from more effective treatments forspecific symptoms.

For another example, a surgeon may plan a certain intervention but notfully execute the plan for any one or more reasons, e.g., wrong sitesurgery, unintended malposition of a device, and inadequatedecompression of a nerve or alignment of anatomic elements.

For yet another example, a large portion of the representative's time isspent in the operating room during routine procedures in which therepresentative's assistance is rarely if ever necessary. Therepresentative also spends a significant amount of time completingpaperwork and performing surgical planning, inventory management, andother logistical tasks. This time could be better spent supporting morecomplex surgeries in which representative input is crucial, orgenerating new business for the medical device company. Furthermore,there are significant costs associated with employing a large staff ofrepresentatives.

These models also suffer from a number of inventory-relatedinefficiencies. For example, in the field of orthopedics, medical devicekits are typically assembled so as to provide the necessary implants,tools, and instruments for any of a variety of types of surgery, rangingfrom the most routine to extraordinarily complex. As a result, many ofthe medical devices in the kit are not used during routine procedures,and are needlessly transported, inventoried, tracked, processed,sterilized, etc.

Accordingly, there remains a need for improved systems and methods forsurgical and interventional planning, support, post-operative follow-up,and functional recovery tracking.

SUMMARY

The present invention generally provides systems and methods forsurgical and interventional planning, support, post-operative follow-up,and functional recovery tracking.

In one aspect, a medical system is provided that in one embodimentincludes a processor configured to receive treatment plan data regardinga plurality of patients. The treatment plan data includes a plan ofmedical treatment corresponding to each of the patients. Each of theplans have associated therewith at least one medical diagnosis in commonwith all of the plans. The processor is also configured to determineeffectiveness of each of the plans and to determine a suggested plan ofmedical treatment for a patient based on the determined effectiveness.The patient has the at least one medical diagnosis. The processor isalso configured to provide the suggested plan to a user.

The system can vary in any number of ways. For example, the processorcan be configured to receive compliance data regarding compliance of thepatients with their corresponding plans, and determining theeffectiveness can include determining based on the compliance data anextent of each patient's compliance with their corresponding plans.Determining the suggested plan can include choosing at least a one ofthe plans having a highest level of compliance. For another example, theplans for a first subset of the patients can include a non-surgicaltreatment, the plans for a second subset of the patients can include asurgical treatment, and determining the suggested plan can includecomparing outcomes of the non-surgical treatments with outcomes of thesurgical treatments. Determining the suggested plan can include choosingat least a one of the plans having a best outcome among the surgicaltreatments and the non-surgical treatments. For still another example,determining the effectiveness can include determining an effect of eachof the plans on the at least one medical diagnosis, and determining thesuggested plan can include choosing at least a one of the plans having amost desired effect on the at least one medical diagnosis. For anotherexample, the processor can be configured to receive performance dataregarding performances of surgical procedures included in each of theplans that include performance of the surgical procedure as at leastpart of the medical treatment, and determining the effectiveness caninclude choosing at least a one of the plans based at least on theperformance data. For another example, the system can include a display,and providing the suggested plan can include showing the suggested planon the display.

In another embodiment, a medical system is provided in that includes astorage unit and a processor. The storage unit is configured to store aplurality of medical diagnoses and store a plurality of medicaltreatments. Each of the diagnoses has a plurality of patient-specificfactors associated therewith. The patient-specific factors include atleast symptoms. Each of the treatments having one or more of the medicaldiagnoses associated therewith. The storage unit also stores aneffectiveness of each of the treatments as related to their associatedone or more medical diagnoses. The processor is configured to receivesymptom data indicating a plurality of symptoms experienced by apatient, determine which one or more of the stored medical diagnoses areassociated with the received plurality of symptoms, provide thedetermined medical diagnoses to a user, determine which one or more ofthe treatments are associated with the determined medical diagnoses, andprovide at least one of the determined treatments to the user. The atleast one of the determined treatments has the highest effectivenessassociated therewith.

The system can have any number of variations. For example, the storedeffectiveness for each of the treatments can be based on any one or moreof compliances of previous patients with a treatment plan associatedwith the treatment, an effect of the treatment on the one or moremedical diagnoses associated therewith, an outcome a surgical procedureincluded as part of the treatment, and compliances of previous patientswith a post-surgery treatment plan associated with the surgicalprocedure. For another example, the system can include a display.Providing the determined medical diagnoses can include showing thedetermined medical diagnoses on the display, and providing the at leastone of the determined treatments can include showing the at least one ofthe determined treatments on the display.

In another embodiment, a medical system is provided that includes aprocessor configured to receive plan data regarding a virtualperformance of a surgical procedure on a patient, and to receiveperformance data regarding an actual performance of the surgicalprocedure on the patient. The performance data is received in real timewith the actual performance of the surgical procedure. The processor isalso configured to determine if the plan data varies from theperformance data. If the plan data is determined to vary from theperformance data, the processor is configured to provide a warning to auser and to repeat the determining for subsequent performance datareceived in real time with the actual performance of the surgicalprocedure. The warning includes an indication of the determinedvariance. If the plan data is determined to not vary from theperformance data, the processor is configured to repeat the determiningfor subsequent performance data received in real time with the actualperformance of the surgical procedure.

The system can vary in any number of ways. For example, the processorcan be configured to receive plan data regarding a plurality of virtualperformances of the surgical procedure on a plurality of patients, andto receive performance data regarding a plurality actual performances ofthe surgical procedure on the plurality of patients. The performancedata is received in real time with the actual performances of thesurgical procedures. The processor can also be configured to determineif the plan data regarding the plurality of virtual performances variesfrom the performance data regarding the plurality actual performances,determine if any one or more of the determined variances are a same typeof variance, and provide a recommendation to a user performing anothervirtual performance of the surgical procedure based on the one or moredetermined variances determined to be the same type of variance. Foranother example, the indication of the determined variance can include arecommended course of action to match the actual performance of thesurgical procedure to the virtual performance of a surgical procedure.For yet another example, the processor can be configured to collate allof the determined variances of the plan data from the performance dataand of the plan data for the subsequent performance data, and to providethe collated determined variances in a report. The report can be a paperreport or an electronic report. For yet another example, a type of thereceived performance data can include at least one of data regardingmovement of a surgical instrument being used in the actual performanceof the surgical procedure, movement of staff present for the actualperformance of the surgical procedure, patient vital signs,identification of a surgical instrument being used in the actualperformance of the surgical procedure, identification of staff presentin the actual performance of the surgical procedure, an amount of tissueretraction, a duration of tissue retraction, and one or more real timeimages of the patient acquired during the actual performance of thesurgical procedure. A type of the received plan data can correspond tothe type of the received performance data. For still another example,the determined variance can include at least one of a surgicalinstrument being moved relative to the patient than in the actualperformance of the surgical procedure different than in the virtualperformance of the surgical procedure, a surgical implant being used inthe actual performance of the surgical procedure being implanted at adifferent location within the patient than the surgical implant used inthe virtual performance of the surgical procedure, different radiationexposures in the actual performance of the surgical procedure and thevirtual performance of the surgical procedure, different lengths oftissue retraction time in the actual performance of the surgicalprocedure and the virtual performance of the surgical procedure,different pharmaceutical administration to the patient in the actualperformance of the surgical procedure than in the virtual performance ofthe surgical procedure, a different number of staff being present in theactual performance of the surgical procedure than a number of virtualstaff present in the virtual performance of the surgical procedure, adifferent duration of a step in the actual performance of the surgicalprocedure than in the virtual performance of the surgical procedure, adifferent surgical instrument being used in a step of the actualperformance of the surgical procedure than in the virtual performance ofthe surgical procedure, and a step performed in the virtual performanceof the surgical procedure not having been performed in the actualperformance of the surgical procedure. For another example, the warningcan include at least one of an audible sound, an illuminated light, aflashing light, a vibration of a surgical instrument being used in theactual performance of the surgical procedure, and a text warning on adisplay.

In another embodiment, a medical system is provided that includes aprocessor configured to receive post-surgery treatment plan dataregarding a plurality of patients. The post-surgery treatment plan dataincludes a plan of medical treatment corresponding to each of thepatients. Each of the plans has associated therewith at least onesurgical procedure in common with all of the plans. The processor isalso configured to determine an effectiveness of each of the plans, andto determine a suggested plan of medical treatment for a patient basedon the determined effectiveness. The patient has had the at least onesurgical procedure performed thereon. The processor is also configuredto provide the suggested plan to a user.

The system can have any number of variations. For example, the processorcan be configured to receive compliance data regarding compliance of thepatients with their corresponding plans, and determining theeffectiveness can include determining based on the compliance data anextent of each patient's compliance with their corresponding plans.Determining the suggested plan can include choosing at least a one ofthe plans having a highest level of compliance. For another example,determining the effectiveness can include determining an effect of eachof the plans on at least one medical diagnosis, and determining thesuggested plan can include choosing at least a one of the plans having amost desired effect on the at least one medical diagnosis. The patienthas been diagnosed with the at least one medical diagnosis. For yetanother example, the system can include a display, and providing thesuggested plan can include showing the suggested plan on the display.

In another embodiment, a medical system is provided that includes adiagnosis and treatment module, a pre-op module, an operation module, apost-op module, and a recovery module. The diagnosis and treatmentmodule receives information regarding a plurality of symptoms of apatient from the patient, receives augmented information regarding theplurality of symptoms of the patient from a medical professional,provides a recommended non-surgical treatment for the patient based onat least the information regarding the plurality of symptoms and theaugmented information, allows selection of a non-surgical treatment forthe patient from a plurality of available non-surgical treatmentsincluding at least the recommended non-surgical treatment, receivesinformation regarding compliance of the patient with the selectednon-surgical treatment, provides a recommended invasive treatment forthe patient based on at least one of the information regardingcompliance, the information regarding the plurality of symptoms, and theaugmented information, and allows selection of an invasive treatment forthe patient from a plurality of available invasive treatments includingat least the recommended invasive treatment. The pre-op module allows athree-dimensional electronic simulation of the selected invasivetreatment to be performed on a virtual patient using a plurality ofvirtual instruments. The virtual patient is a model of the patient basedon gathered medical data regarding the patient, and each of theplurality of virtual instruments are modeled on an actual instrumentavailable for use in the selected invasive treatment. The pre-op modulealso stores the electronic simulation in a storage unit. The operationmodule compares an actual performance of the selected invasive treatmenton the patient with the stored electronic simulation, provideselectronic feedback regarding the comparison during the actualperformance of the selected invasive treatment that indicates progressof the actual performance of the selected invasive treatment versus thestored electronic simulation, triggers an alarm if the comparisonindicates that a step of the actual performance of the selected invasivetreatment differs from the stored electronic simulation beyond apredetermined threshold amount of tolerable variance, and stores dataregarding the actual performance of the selected invasive treatment inthe storage unit. The post-op module compares the stored electronicsimulation with the stored data regarding the actual performance of theselected invasive treatment, and, based on the comparison of the storedelectronic simulation with the stored data regarding the actualperformance of the selected invasive treatment, determines a variancebetween the stored electronic simulation and the stored data regardingthe actual performance of the selected invasive treatment in the storageunit. The recovery module provides a recommended post-op treatment planfor the patient based on at least the stored data regarding the actualperformance of the selected invasive treatment, allows selection of apost-op treatment for the patient from a plurality of available post-optreatments including at least the recommended post-op treatment,receives information regarding compliance of the patient with theselected post-op treatment plan, and provides a recommended follow-uptreatment for the patient based at least on the information regardingcompliance of the patient with the recommended post-op treatment plan.

The system can vary in any number of ways. For example, the system caninclude a processor configured to execute the functions performed by thediagnosis and treatment module, the pre-op module, the operation module,the post-op module, and the recovery module. The system can also includea storage unit storing the diagnosis and treatment module, the pre-opmodule, the operation module, the post-op module, and the recoverymodule. The processor and the storage unit can be included in a singularunit. The system can be provided with only a subset of the diagnosis andtreatment module, the pre-op module, the operation module, the post-opmodule, and the recovery module. Each of the diagnosis and treatmentmodule, the pre-op module, the operation module, the post-op module, andthe recovery module can be modular components such that any one or moreof the diagnosis and treatment module, the pre-op module, the operationmodule, the post-op module, and the recovery module can be selectivelyadded to the system and removed from the system.

The diagnosis and treatment module can vary in any number of ways. Forexample, the diagnosis and treatment module can receive informationregarding at least one of a plurality of patient-specific factorsregarding the patient. The patient-specific factors can include any oneor more of physical examination data, images of the patient, laboratorytest results for the patient, demographic data for the patient, and/oron historical tests for the patient. Receiving the information regardingthe at least one of the plurality of patient-specific factors caninclude receiving data from a plurality of sensors, e.g., a smartphonecamera. The recovery module can receive information from the pluralityof sensors after the actual performance of the selected invasivetreatment. The recommended follow-up treatment can be based at least inpart on the information from the plurality of sensors. The informationregarding the at least one of the plurality of patient-specific factorscan include receiving data regarding a scoliotic curve of the patient.The diagnosis and treatment module can provide modeling of potentialcurve progression to the patient based at least in part on the dataregarding the scoliotic curve. The recovery module can provide modelingof potential curve progression to the patient based at least in part onthe data regarding the scoliotic curve and on the stored data regardingthe actual performance of the selected invasive treatment. Theinformation regarding the at least one of the plurality ofpatient-specific factors can include receiving data regarding any one ormore of mobility, gait, walking speed, flexibility, muscular strength,posture, range of motion, pain, neurologic tracking, joint movementtracking, bone density, and musculo-skeletal pain levels. For bonedensity, the diagnosis and treatment module can be configured to gatherthe bone density information using an image of the patient including animage of a bone density marker including a first material having a firstdensity and a second material having a second density.

For another example, the diagnosis and treatment module receiving theinformation regarding the plurality of symptoms can include receivingdata from a plurality of sensors, e.g., a smartphone camera. Therecovery module can receive information from the plurality of sensorsafter the actual performance of the selected invasive treatment. Therecommended follow-up treatment can be based at least in part on theinformation from the plurality of sensors. For yet another example, thediagnosis and treatment module receiving the information regarding theplurality of symptoms can include receiving data from a neural mappingdevice. The diagnosis and treatment module can measure a pain level ofthe patient by comparing the patient's neural map and associatedself-described pain scores to a plurality of neural maps regarding aplurality of other patients and to a plurality of self-described painscores of the plurality of other patients, thereby allowing thediagnosis and treatment module to normalize the self-described painlevels of the patient and the plurality of other patients. For anotherexample, the diagnosis and treatment module can provide a historicalsuccess rate for each of the plurality of available surgical treatments.For yet another example, the diagnosis and treatment module can provideaccess to one or more knowledge sources regarding the recommendedinvasive treatment. The knowledge resources can include any one or moreof print literature, electronic literature, training, and experts. Forstill another example, the diagnosis and treatment module can provide asuggested diagnosis for the patient based on at least the informationregarding the plurality of symptoms and the augmented information. Thediagnosis and treatment module can provide the suggested diagnosiscomprises providing a plurality of suggested diagnoses. Each of theplurality of suggested diagnoses can be provided with a level ofconfidence based at least on historical accuracy of the diagnosis forpatients having similar symptoms to the plurality of symptoms. Thelevels of confidence can be based at least on a comparison of aplurality of attributes associated with the patient and a plurality ofattributes associated with the diagnosis. For another example, thediagnosis and treatment module providing the recommended non-surgicaltreatment can include providing a plurality of recommended non-surgicaltreatments. Each of the plurality of recommended non-surgical treatmentscan be provided with a level of confidence of success based at least onhistorical outcomes of the non-surgical treatment. The levels ofconfidence can be based at least on a comparison of a plurality ofattributes associated with the patient and a plurality of attributesassociated with the non-surgical treatment. For yet another example, thediagnosis and treatment module providing the recommended invasivetreatment can include providing a plurality of recommended invasivetreatments. Each of the plurality of recommended invasive treatments canbe provided with a level of confidence of success based at least onhistorical outcomes of the invasive treatment. The levels of confidencecan be based at least on a comparison of a plurality of attributesassociated with the patient and a plurality of attributes associatedwith the invasive treatment.

The pre-op module can vary in any number of ways. For example, thepre-op module can monitor the patient in a hospital prior to performanceof the actual performance of the selected invasive treatment at thehospital. The monitoring can include at least one of vital signs of thepatient, pre-op preparations performed on the patient, and a location ofthe patient in the hospital. Based on the monitoring, the pre-op modulecan trigger at least one of an operating room preparation for the actualperformance of the selected invasive treatment and a recovery roompreparation for the actual performance of the selected invasivetreatment.

The operation module can have any number of variations. For example, theoperation module can track a number of instruments used in the actualperformance of the selected invasive procedure. For another example, theoperation module can track a number of times each of the instrumentsused in the actual performance of the selected invasive procedure havebeen used in a plurality of invasive procedures. The post-op module cantrigger an alarm when the number of times for any one or more of theinstruments exceeds a predetermined threshold number, the predeterminedthreshold number reflecting at least one of a maximum number of times aninstrument can be used in invasive procedures before needing sharpening,a maximum number of times an instrument can be used in invasiveprocedures before needing lubrication, a maximum number of times aninstrument can be used in invasive procedures before needingreplacement, and a maximum number of times an instrument can be used ininvasive procedures before needing calibration. For yet another example,the operation module can determine when any one or more of a non-sterileperson and a non-sterile instrument enters an area in which the actualperformance of the selected invasive treatment is being performed, andin response to the determination, trigger an alarm indicating breach ofsterility in the area. For another example, the operation module canidentify an instrument to be used in the actual performance of theselected invasive procedure and provide an indication of a position ofthe instrument in an instrument tray to be provided in an area in whichthe actual performance of the selected invasive procedure will beperformed. The indication can include at least one of an audio signaland a visual signal. For another example, the operation module cangather data for a medical practitioner involved in the actualperformance of the selected invasive procedure in a period of timefollowing the invasive procedure. The data can include an energy levelof the medical practitioner and nutrition of the medical practitioner.The post-op module can compare the gathered data for the medicalpractitioner with the stored data regarding the actual performance ofthe selected invasive treatment so as to determine recommendedimprovements in the energy level and the nutrition. For yet anotherexample, the operation module can provide the electronic feedback on adisplay, and the operation module can provide additional electronicinformation regarding the actual performance of the selected invasivetreatment on the display including any one or more of a fluoroscopicimage of the patient, vital signs of the patient, neural monitoringoutputs, surgical techniques videos, camera feeds from outside a roomwhere the selected invasive treatment is being performed, power usage ofinstruments, and controls for any one or more devices that gather theadditional electronic information and provide the additional electronicinformation to the operation module. For still another example, theoperation module can provide feedback regarding a position of thepatient in a room where the selected invasive treatment is to beperformed. The feedback can provide guidance on movement of the patientsuch that the position of the patient matches a predetermined optimalposition of the patient for performance of the selected invasivetreatment. The feedback can be based at least one any one or more ofimages of the patient in the room and images of the patient acquiredprior to the patient being located in the room. For another example, theoperation module can allow for user selection of anatomy of the patientto be shown on a display in any one or more of a plurality ofvisualization options, e.g., 3D images, holograms, and projections. Foryet another example, the operation module can show the electronicfeedback on a display and allows user selection of different informationto be shown on the display using a no-touch control operable by a user.The no-touch control can include at least one of a data board, agesture-based control, and direct brain control. For still anotherexample, the comparing of the operation module can include comparing anamount of spinal disc clearing of the stored electronic simulation withan actual amount of spinal disc clearing. For another example, theoperation module can determine an instrument needed for an upcomingaspect of the actual performance of the selected invasive treatment andautomatically trigger sterilization and retrieval of the determinedinstrument. For yet another example, the operation module can determineat least one of a time length of retraction of a tissue during theactual performance of the selected invasive treatment, an amount of thetissue retraction, and an amount of pressure being placed on at leastone of tissue and nerves as a result of the retraction, and theoperation module can trigger an alarm if any one or more of the timelength reaches a predetermined threshold amount of time, the amount oftissue retraction reaches a predetermined amount of tissue, and theamount of pressure reaches a predetermined amount of pressure. Foranother example, the comparing of the operation module can includecomparing a trajectory of an instrument in the stored electronicsimulation with an actual trajectory of the instrument in the actualperformance of the selected invasive treatment, and if the actualtrajectory differs from the trajectory, the operation module can providea warning indicating that the trajectories differ. For yet anotherexample, the operation module can provide information regarding nervesof the patient during in the actual performance of the selected invasivetreatment. The nerve information can include at least one of a visualoverlay of nerves on the patient and an augmented reality view of thenerves.

The post-op module can have any number of variations. For example, thepost-op module can gather data for each medical practitioner involved inthe actual performance of the selected invasive procedure in a period oftime following the invasive procedure. The invasive procedure can beperformed in an operating room, and the data can include an energy levelof the medical practitioner and nutrition of the medical practitioner.The post-op module can compare the gathered data with data stored in thestorage unit regarding actual performance of invasive treatments in theoperating room so as to determine recommended improvements in the energylevel and the nutrition.

In another aspect, a medical method is provided that in one embodimentincludes the functions performed by the diagnosis and treatment module,the pre-op module, the operation module, the post-op module, and therecovery module.

In another embodiment, a medical method is provided that includesreceiving treatment plan data regarding a plurality of patients. Thetreatment plan data includes a plan of medical treatment correspondingto each of the patients. Each of the plans has associated therewith atleast one medical diagnosis in common with all of the plans. The methodalso includes determining an effectiveness of each of the plans, anddetermining a suggested plan of medical treatment for a patient based onthe determined effectiveness. The patient has the at least one medicaldiagnosis. The method also includes providing the suggested plan to auser.

The method can vary in any number of ways. For example, the method caninclude receiving compliance data regarding compliance of the patientswith their corresponding plans, and determining the effectiveness caninclude determining based on the compliance data an extent of eachpatient's compliance with their corresponding plans. Determining thesuggested plan can include choosing at least a one of the plans having ahighest level of compliance. For another example, the plans for a firstsubset of the patients can include a non-surgical treatment, the plansfor a second subset of the patients can include a surgical treatment,and determining the suggested plan can include comparing outcomes of thenon-surgical treatments with outcomes of the surgical treatments.Determining the suggested plan can include choosing at least a one ofthe plans having a best outcome among the surgical treatments and thenon-surgical treatments. For yet another example, determining theeffectiveness can include determining an effect of each of the plans onthe at least one medical diagnosis, and determining the suggested plancan include choosing at least a one of the plans having a most desiredeffect on the at least one medical diagnosis. For another example, themethod can include receiving performance data regarding performances ofsurgical procedures included in each of the plans that includeperformance of the surgical procedure as at least part of the medicaltreatment, and determining the effectiveness can include choosing atleast a one of the plans based at least on the performance data. For yetanother example, providing the suggested plan can include showing thesuggested plan on a display.

In another embodiment, a medical method is provided that includesstoring a plurality of medical diagnoses and storing a plurality ofmedical treatments. Each of the diagnoses has a plurality ofpatient-specific factors associated therewith. The patient-specificfactors include at least symptoms. Each of the treatments has one ormore of the medical diagnoses associated therewith. The method alsoincludes storing an effectiveness of each of the treatments as relatedto their associated one or more medical diagnoses, receiving symptomdata indicating a plurality of symptoms experienced by a patient,determining which one or more of the stored medical diagnoses areassociated with the received plurality of symptoms, providing thedetermined medical diagnoses to a user, determining which one or more ofthe treatments are associated with the determined medical diagnoses, andproviding at least one of the determined treatments to the user. The atleast one of the determined treatments has the highest effectivenessassociated therewith.

The method can have any number of variations. For example, the storedeffectiveness for each of the treatments can be based on any one or moreof compliances of previous patients with a treatment plan associatedwith the treatment, an effect of the treatment on the one or moremedical diagnoses associated therewith, an outcome a surgical procedureincluded as part of the treatment, and compliances of previous patientswith a post-surgery treatment plan associated with the surgicalprocedure. For another example, providing the determined medicaldiagnoses can include showing the determined medical diagnoses on adisplay, and providing the at least one of the determined treatments caninclude showing the at least one of the determined treatments on thedisplay.

In another embodiment, a medical method is provided that includesreceiving plan data regarding a virtual performance of a surgicalprocedure on a patient, and receiving performance data regarding anactual performance of the surgical procedure on the patient. Theperformance data is received in real time with the actual performance ofthe surgical procedure. The method also includes determining if the plandata varies from the performance data. If the plan data is determined tovary from the performance data, a warning is provided to a user, and thedetermining is repeated for subsequent performance data received in realtime with the actual performance of the surgical procedure. The warningincludes an indication of the determined variance. If the plan data isdetermined to not vary from the performance data, the determining isrepeated for subsequent performance data received in real time with theactual performance of the surgical procedure.

The method can have any number of variations. For example, the methodcan include receiving plan data regarding a plurality of virtualperformances of the surgical procedure on a plurality of patients, andreceiving performance data regarding a plurality actual performances ofthe surgical procedure on the plurality of patients. The performancedata is received in real time with the actual performances of thesurgical procedures. The method also includes determining if the plandata regarding the plurality of virtual performances varies from theperformance data regarding the plurality actual performances,determining if any one or more of the determined variances are a sametype of variance, and providing a recommendation to a user performinganother virtual performance of the surgical procedure based on the oneor more determined variances determined to be the same type of variance.For another example, the indication of the determined variance caninclude a recommended course of action to match the actual performanceof the surgical procedure to the virtual performance of a surgicalprocedure. For yet another example, the method can include collating allof the determined variances of the plan data from the performance dataand of the plan data for the subsequent performance data, and providingthe collated determined variances in a report. The report can be a paperreport or an electronic report. For yet another example, a type of thereceived performance data can include at least one of data regardingmovement of a surgical instrument being used in the actual performanceof the surgical procedure, movement of staff present for the actualperformance of the surgical procedure, patient vital signs,identification of a surgical instrument being used in the actualperformance of the surgical procedure, identification of staff presentin the actual performance of the surgical procedure, an amount of tissueretraction, a duration of tissue retraction, and one or more real timeimages of the patient acquired during the actual performance of thesurgical procedure. A type of the received plan data can correspond tothe type of the received performance data. For still another example,the determined variance can include at least one of a surgicalinstrument being moved relative to the patient than in the actualperformance of the surgical procedure different than in the virtualperformance of the surgical procedure, a surgical implant being used inthe actual performance of the surgical procedure being implanted at adifferent location within the patient than the surgical implant used inthe virtual performance of the surgical procedure, different radiationexposures in the actual performance of the surgical procedure and thevirtual performance of the surgical procedure, different lengths oftissue retraction time in the actual performance of the surgicalprocedure and the virtual performance of the surgical procedure,different pharmaceutical administration to the patient in the actualperformance of the surgical procedure than in the virtual performance ofthe surgical procedure, a different number of staff being present in theactual performance of the surgical procedure than a number of virtualstaff present in the virtual performance of the surgical procedure, adifferent duration of a step in the actual performance of the surgicalprocedure than in the virtual performance of the surgical procedure, adifferent surgical instrument being used in a step of the actualperformance of the surgical procedure than in the virtual performance ofthe surgical procedure, and a step performed in the virtual performanceof the surgical procedure not having been performed in the actualperformance of the surgical procedure. For another example, the warningcan include at least one of an audible sound, an illuminated light, aflashing light, a vibration of a surgical instrument being used in theactual performance of the surgical procedure, and a text warning on adisplay.

In another embodiment, a medical method is provided that includesreceiving post-surgery treatment plan data regarding a plurality ofpatients. The post-surgery treatment plan data includes a plan ofmedical treatment corresponding to each of the patients. Each of theplans has associated therewith at least one surgical procedure in commonwith all of the plans. The method also includes determining aneffectiveness of each of the plans, and determining a suggested plan ofmedical treatment for a patient based on the determined effectiveness.The patient has had the at least one surgical procedure performedthereon. The method also includes providing the suggested plan to auser.

The method can vary in any number of ways. For example, the method caninclude receiving compliance data regarding compliance of the patientswith their corresponding plans, and determining the effectiveness caninclude determining based on the compliance data an extent of eachpatient's compliance with their corresponding plans. Determining thesuggested plan can include choosing at least a one of the plans having ahighest level of compliance. For another example, determining theeffectiveness can include determining an effect of each of the plans onat least one medical diagnosis, and determining the suggested plan caninclude choosing at least a one of the plans having a most desiredeffect on the at least one medical diagnosis. The patient has beendiagnosed with the at least one medical diagnosis. For yet anotherexample, providing the suggested plan can include showing the suggestedplan on a display.

In another aspect, a computer-readable medium is provided and has storedthereon a program that when executed can cause a computer to perform anyof the methods.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a schematic diagram of an embodiment of a computer system;

FIG. 2 is a schematic diagram of an embodiment a diagnosis, surgicalplanning, support, and management system;

FIG. 3 is a schematic diagram of an embodiment of a network systemincluding the diagnosis, surgical planning, support, and managementsystem of FIG. 2;

FIG. 4 is a schematic diagram of an embodiment of a continuum of patientcare for the diagnosis, surgical planning, support, and managementsystem of FIG. 2;

FIG. 5 is a perspective view of an embodiment of a client terminal thatallows user input of data to the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 5A is a schematic view of an embodiment of a user interface thatallows user input of data to the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 5B is a schematic view of another embodiment of a user interfacethat allows user input of data to the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 5C is a schematic view of yet another embodiment of a userinterface that allows user input of data to the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 6 is a perspective view of another embodiment of a client terminalthat allows user input of data to the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 7 is a perspective view of an embodiment of a bone density markersystem that provides bone density information to diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 8 is a perspective view of yet another embodiment of a clientterminal that allows user input of data to the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 9 is a perspective view of an embodiment of a simulated surgicalprocedure display provided by the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 10 is a perspective view of an embodiment of a topographicalmapping system that provides topographical mapping information to thediagnosis, surgical planning, support, and management system of FIG. 2;

FIG. 11 is a perspective view of an embodiment of a client terminal inan OR setting that communicates with the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 12 is a perspective view of another embodiment of a client terminalin an OR setting that communicates with the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 13 is a perspective view of yet another embodiment of a clientterminal in an OR setting that communicates with the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 14 is a perspective view of an embodiment of a client terminalshowing surgical progress data received from the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 15 is a perspective view of an embodiment of a client terminalshowing patient data received from the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 16 is a perspective view of an embodiment of a client terminalshowing surgical instrument data received from the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 17A is a perspective view of an embodiment of projection systemthat communicates with the diagnosis, surgical planning, support, andmanagement system of FIG. 2;

FIG. 17B is a perspective view of one of the projectors of theprojection system of FIG. 17A;

FIG. 18 is a perspective view of an embodiment of a motion sensingsystem that communicates with the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 19 is a perspective view of an embodiment of a direct braininterface system that communicates with the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 20 is a perspective view of an embodiment of a no-touch datacommunication system that communicates with the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 21 is a perspective view of an embodiment of a visual position andorientation tracking system that communicates with the diagnosis,surgical planning, support, and management system of FIG. 2;

FIG. 22 is a perspective view of an embodiment of an anatomicalvisualization for a spinal surgery provided by the diagnosis, surgicalplanning, support, and management system of FIG. 2;

FIG. 23 is a perspective view of an embodiment of a void confirmationsystem that communicates with the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 24 is a perspective view of an embodiment of an instrument trackingsystem that communicates with the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 25 is a perspective view of another embodiment of a skin surfacemapping and instrument tracking system that communicates with thediagnosis, surgical planning, support, and management system of FIG. 2;

FIG. 26 is a perspective view of an embodiment of an instrument sortingsystem that communicates with the diagnosis, surgical planning, support,and management system of FIG. 2;

FIG. 27 is a perspective view of an embodiment of a client terminalshowing post-op surgical procedure data received from the diagnosis,surgical planning, support, and management system of FIG. 2;

FIG. 28 is a perspective view of an embodiment of a client terminalshowing post-op treatment plan data received from the diagnosis,surgical planning, support, and management system of FIG. 2;

FIG. 29A is a perspective view of an embodiment of a patient on a bed ina surgical setting;

FIG. 29B is a series of perspective views of an embodiment of a pedicledemonstrating vertebral body translation which converts a pedicletrajectory from a first position to a second horizontal or plumbposition;

FIG. 30 is a top, partially transparent view of an embodiment of apatient on a bed in a surgical setting with desired vertebral angles;

FIG. 31 is a perspective view of an embodiment of a fluoroscopic imageof a lumbar spine of a patient in a baseline position;

FIG. 32 is a perspective view of an embodiment of a fluoroscopic imageof the lumbar spine of the patient of FIG. 31, the lumbar spine being inan initial surgical position;

FIG. 33 is a perspective view of an embodiment of a fluoroscopic imageof the lumbar spine of the patient of FIG. 32, the lumbar spine movedfrom the initial surgical position to an adjusted surgical position;

FIG. 34A shows a flowchart of an exemplary embodiment of using adiagnosis and treatment module of the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 34B shows another portion of the flowchart of FIG. 34A;

FIG. 35 shows a flowchart of another exemplary embodiment of using adiagnosis and treatment module of the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 36 shows a flowchart of another exemplary embodiment of using adiagnosis and treatment module of the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 37 shows a flowchart of another exemplary embodiment of using adiagnosis and treatment module of the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 38-1 shows a portion of a flowchart of an exemplary embodiment ofusing a pre-op module of the diagnosis, surgical planning, support, andmanagement system of FIG. 2;

FIG. 38-2 shows another portion of the flowchart of FIG. 38-1;

FIG. 39A-1 shows a portion of a flowchart of another exemplaryembodiment of using a pre-op module of the diagnosis, surgical planning,support, and management system of FIG. 2;

FIG. 39A-2 shows another portion of the flowchart of FIG. 39A-1;

FIG. 39B-1 shows another portion of the flowchart of FIG. 39A-1;

FIG. 39B-2 shows another portion of the flowchart of FIG. 39A-1;

FIG. 39B-3 shows another portion of the flowchart of FIG. 39A-1;

FIG. 39C shows another portion of the flowchart of FIG. 39A-1;

FIG. 40 shows a flowchart of another exemplary embodiment of using apre-op module of the diagnosis, surgical planning, support, andmanagement system of FIG. 2;

FIG. 41A shows a flowchart of an exemplary embodiment of using anoperation module of the diagnosis, surgical planning, support, andmanagement system of FIG. 2;

FIG. 41B-1 shows another portion of the flowchart of FIG. 41A;

FIG. 41B-2 shows another portion of the flowchart of FIG. 41A;

FIG. 41C shows another portion of the flowchart of FIG. 41A;

FIG. 42A shows a flowchart of another exemplary embodiment of using anoperation module of the diagnosis, surgical planning, support, andmanagement system of FIG. 2;

FIG. 42B shows another portion of the flowchart of FIG. 42A.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention

Various systems and methods are provided for systems and methods forsurgical and interventional planning, support, post-operative follow-up,and functional recovery tracking. In general, a patient can be trackedthroughout medical treatment including through initial onset ofsymptoms, examination and diagnosis, non-surgical treatment, surgicaltreatment, and recovery from the surgical treatment. In one embodiment,a patient and one or more medical professionals involved with treatingthe patient can electronically access a comprehensive treatmentplanning, support, and review system, e.g., using one or more web pages.The system can provide recommendations regarding diagnosis, non-surgicaltreatment, surgical treatment, and recovery from the surgical treatmentbased on data gathered from the patient and the medical professional(s),thereby helping to improve accuracy in diagnosis and effectiveness oftreatment. The system can manage the tracking of multiple patients,thereby allowing for data comparison between similar aspects of medicaltreatments, e.g., between similar non-surgical treatments, and forlearning over time through continual data gathering, analysis, andassimilation to decision-making algorithms. The system can thereforehelp improve accuracy of diagnosis and effectiveness of treatment formultiple patients by considering previously gathered data, including,e.g., historic success rates as measured in Health-Related Quality ofLife (HRQOL), utilization, and health/economic parameters, regardingsimilar diagnoses and treatments in providing suggested diagnoses andrecommended treatments. The model can also facilitate various tasksassociated with surgical planning, inventory planning, intra-operativesupport, post-surgery logistics, and billing phases of patienttreatment. The system can allow for documentation and tracking of theprogression of the patient throughout at least some phases of thepatient's treatment, and in an exemplary embodiment all phases, whichcan be highly beneficial to non-surgical and surgical treatment of thepatient as well as for informing decisions regarding non-surgical andsurgical treatments of other patients.

Computer System

The systems and methods disclosed herein can be implemented using one ormore computer systems, which are also referred to herein as digital dataprocessing systems.

FIG. 1 illustrates one exemplary embodiment of a computer system 100. Asshown, the computer system 100 can include one or more processors 102which can control the operation of the computer system 100. Theprocessor(s) 102 can include any type of microprocessor or centralprocessing unit (CPU), including programmable general-purpose orspecial-purpose microprocessors and/or any one of a variety ofproprietary or commercially available single or multi-processor systems.The computer system 100 can also include one or more memories 104, whichcan provide temporary storage for code to be executed by theprocessor(s) 102 or for data acquired from one or more users, storagedevices, and/or databases. The memory 104 can include read-only memory(ROM), flash memory, one or more varieties of random access memory (RAM)(e.g., static RAM (SRAM), dynamic RAM (DRAM), or synchronous DRAM(SDRAM)), and/or a combination of memory technologies.

The various elements of the computer system 100 can be coupled to a bussystem 112. The illustrated bus system 112 is an abstraction thatrepresents any one or more separate physical busses, communicationlines/interfaces, and/or multi-drop or point-to-point connections,connected by appropriate bridges, adapters, and/or controllers. Thecomputer system 100 can also include one or more network interface(s)106, one or more input/output (IO) interface(s) 108, and one or morestorage device(s) 110.

The network interface(s) 106 can enable the computer system 100 tocommunicate with remote devices, e.g., other computer systems, over anetwork, and can be, for non-limiting example, remote desktop connectioninterfaces, Ethernet adapters, and/or other local area network (LAN)adapters. The IO interface(s) 108 can include one or more interfacecomponents to connect the computer system 100 with other electronicequipment. For non-limiting example, the IO interface(s) 108 can includehigh speed data ports, such as universal serial bus (USB) ports, 1394ports, Wi-Fi, Bluetooth, etc. Additionally, the computer system 100 canbe accessible to a human user, and thus the IO interface(s) 108 caninclude displays, speakers, keyboards, pointing devices, and/or variousother video, audio, or alphanumeric interfaces. The storage device(s)110 can include any conventional medium for storing data in anon-volatile and/or non-transient manner. The storage device(s) 110 canthus hold data and/or instructions in a persistent state, i.e., thevalue is retained despite interruption of power to the computer system100. The storage device(s) 110 can include one or more hard disk drives,flash drives, USB drives, optical drives, various media cards,diskettes, compact discs, and/or any combination thereof and can bedirectly connected to the computer system 100 or remotely connectedthereto, such as over a network. In an exemplary embodiment, the storagedevice(s) can include a tangible or non-transitory computer readablemedium configured to store data, e.g., a hard disk drive, a flash drive,a USB drive, an optical drive, a media card, a diskette, a compact disc,etc.

The elements illustrated in FIG. 1 can be some or all of the elements ofa single physical machine. In addition, not all of the illustratedelements need to be located on or in the same physical machine.Exemplary computer systems include conventional desktop computers,workstations, minicomputers, laptop computers, tablet computers,personal digital assistants (PDAs), mobile phones, and the like.

The computer system 100 can include a web browser for retrieving webpages or other markup language streams, presenting those pages and/orstreams (visually, aurally, or otherwise), executing scripts, controlsand other code on those pages/streams, accepting user input with respectto those pages/streams (e.g., for purposes of completing input fields),issuing Hypertext Transfer Protocol (HTTP) requests with respect tothose pages/streams or otherwise (e.g., for submitting to a serverinformation from the completed input fields), and so forth. The webpages or other markup language can be in HyperText Markup Language(HTML) or other conventional forms, including embedded Extensible MarkupLanguage (XML), scripts, controls, and so forth. The computer system 100can also include a web server for generating and/or delivering the webpages to client computer systems.

In an exemplary embodiment, the computer system 100 can be provided as asingle unit, e.g., as a single server, as a single tower, containedwithin a single housing, etc. The systems and methods disclosed hereincan thus be provided as a singular unit configured to provide thevarious modules, display the various user interfaces, and capture thedata described herein. The singular unit can be modular such thatvarious aspects thereof can be swapped in and out as needed for, e.g.,upgrade, replacement, maintenance, etc., without interruptingfunctionality of any other aspects of the system. The singular unit canthus also be scalable with the ability to be added to as additionalmodules and/or additional functionality of existing modules are desiredand/or improved upon.

While some embodiments are described herein in the context of web pages,it will be appreciated that in other embodiments, one or more of thedescribed functions can be performed without the use of web pages and/orby other than web browser software. A computer system can also includeany of a variety of other software and/or hardware components, includingby way of non-limiting example, operating systems and databasemanagement systems. Although an exemplary computer system is depictedand described herein, it will be appreciated that this is for sake ofgenerality and convenience. In other embodiments, the computer systemmay differ in architecture and operation from that shown and describedhere.

Diagnosis, Surgical Planning, Support, and Management System Generally

FIG. 2 is a schematic block diagram of one exemplary embodiment of adiagnosis, surgical planning, support, and management system 10. Thesystem 10 can includes a plurality of modules, discussed further below,which can each be implemented using one or more digital data processingsystems of the type described above, and in particular using one or moreweb pages which can be viewed, manipulated, and/or interacted with usingsuch digital data processing systems. The system 10 can thus beimplemented on a single computer system, or can be distributed across aplurality of computer systems. The system 10 also includes a pluralityof databases, which can be stored on and accessed by computer systems.It will be appreciated that any of the modules or databases disclosedherein can be subdivided or can be combined with other modules ordatabases.

Any of a variety of parties can access, interact with, control, etc. thesystem 10 from any of a variety of locations. For non-limiting example,as shown in an embodiment illustrated in FIG. 3, the system 10 can beaccessible over a network 12 (e.g., over the Internet via cloudcomputing) from any number of client stations 14 in any number oflocations such as a medical facility 16 (e.g., a hospital, an operatingroom (OR), a nurse's station, a medical device distribution facility, amedical device company, a hospital's sterilization, records, or billingdepartments, etc.), a home base 18 (e.g., a patient's home or office, asurgeon's home or office, etc.), a mobile location 20, and so forth. Theclient station(s) 14 can access the system 10 through a wired and/orwireless connection to the network 12. In an exemplary embodiment, atleast some of the client terminal(s) 14 can access the system 10wirelessly, e.g., through Wi-Fi connection(s), which can facilitateaccessibility of the system 10 from almost any location in the world. Asshown in FIG. 3, the medical facility 16 includes client stations 14 inthe form of a tablet and a computer touch screen, the home base 18includes client stations 14 in the form of a mobile phone having a touchscreen and a desktop computer, and the mobile location 20 includesclient stations 14 in the form of a tablet and a mobile phone, but themedical facility 16, the home base 18, and the mobile location 20 caninclude any number and any type of client stations. In an exemplaryembodiment, the system 10 can be accessible by a client terminal via aweb address and/or a client application (generally referred to as an“app”).

It will be appreciated that the system 10 can include security featuressuch that the aspects of the system available to any particular user canbe determined based on the identity of the user and/or the location fromwhich the user is accessing the system. To that end, each user can havea unique username, password, and/or other security credentials tofacilitate access to the system 10. The received security parameterinformation can be checked against a database of authorized users todetermine whether the user is authorized and to what extent the user ispermitted to interact with the system, view information stored in thesystem, and so forth. Exemplary, non-limiting examples of parties whocan be permitted to access the system 10 include patients, potentialpatients, significant others, friends, and family members of patients orpotential patients, surgical technicians, imaging technicians (e.g.,x-ray technicians, MRI technicians, etc.), surgeons, nurses, hospitaladministrators, surgical equipment manufacturer employees, insuranceproviders, and operating room directors.

FIG. 4 illustrates an exemplary embodiment of a medical treatmentcontinuum 22 throughout which the system 10 can facilitate diagnosis andtreatment of patients. A patient can be tracked through a partialportion of the continuum 22 or through an entirety of the continuum 22.In this way, the system 10 can be effective for all patients, not justfor patients treated with an invasive procedure such as surgery, needleprocedures, biopsy, catheter based procedures, etc. As discussed herein,the system 10 can allow paths of an individual's medical treatmentthrough all or part of the continuum 22 to be compared and consolidatedthen applied to patients with similar symptoms to diagnose and choosethe treatment that previously produced a best outcome for similarlysituated patients. The outcome can include technical, anatomic,functional, and patient reported parameters. FIG. 4 also illustrates howa number of patients in the continuum 22 is typically greatest in awellness and prevention phase of the continuum 22, second greatest in aconservative therapy phase of the continuum 22, third greatest in aninterventional therapy phase of the continuum 22, and least in surgicalprocedure and post-surgery phases of the continuum 22. Thus, bycomparing and consolidating information regarding patients in the phasesthat typically involve a larger number of patients than invasivelytreated patients, the system 10 can help inform treatment of a largernumber of patients than systems that focus only on surgical treatmentsand/or only on post-diagnosis. The continuum 22 also shows how data fromall of the phases can be received by the system 10, thereby allowingpooling of data that can inform subsequent decisions in any one or morephases of the continuum 22, including phases different from where thedata was originally collected.

The system 10 can include a diagnosis and treatment module 200, a pre-opmodule 202, an operation module 204, a post-op module 206, and arecovery module 208. Any of the diagnosis and treatment module 200, thepre-op module 202, the operation module 204, the post-op module 206, andthe recovery module 208 can be used independently from one another andcan be used in combination with any one or more of the other modules200, 202, 204, 206, 208. In an exemplary embodiment, the diagnosis andtreatment module 200, the pre-op module 202, the operation module 204,the post-op module 206, and the recovery module 208 can be provided as acomprehensive system that can track a patient throughout medicaltreatment including through initial onset of symptoms, diagnosis,non-surgical treatment, surgical and/or other invasive treatment, andrecovery from the invasive treatment. Each of the modules 200, 202, 204,206, 208 is discussed further below in turn. Although each of themodules 200, 202, 204, 206, 208 is illustrated in FIG. 2 as including aplurality of component modules, each of the modules 200, 202, 204, 206,208 can include any number of component modules, e.g., one, two, three,etc., the same or different from any of the other modules 200, 202, 204,206, 208. Further, as mentioned above, it will be appreciated that anyof the modules 200, 202, 204, 206, 208, and any of their variouscomponent modules, can be subdivided or can be combined with othermodules, including modules illustrated in FIG. 2 as being in differentones of the modules 200, 202, 204, 206, 208.

The system 10 can also include a diagnosis and treatment database 300configured to be accessible by the diagnosis and treatment module 200and to store diagnosis and treatment data, a pre-op database 302configured to be accessible by the pre-op module 202 and to store pre-opdata, an operation database 304 configured to be accessible by theoperation module 204 and to store operation data, a post-op database 306configured to be accessible by the post-op module 206 and to storepost-op data, and a recovery database 308 configured to be accessible bythe recovery module 208 and to store recovery data. Each of thedatabases 300, 302, 304, 306, 308 is discussed further below in turnwith respect to their associated modules 200, 202, 204, 206, 208. Eachof the databases 300, 302, 304, 306, 308 can include any number ofcomponent databases, e.g., one, two, three, etc., the same or differentfrom any of the other databases 300, 302, 304, 306, 308. As mentionedabove, it will be appreciated that any of the databases 300, 302, 304,306, 308, and any of their various component databases, can besubdivided or can be combined with other databases, including databasesillustrated in FIG. 2 as being in different ones of the databases 300,302, 304, 306, 308. Any portion of any of the databases 300, 302, 304,306, 308 can be configured to be accessed by any one or more of themodules 200, 202, 204, 206, 208. Although the system 10 in theillustrated embodiment stores data in database(s), any of the systemsdisclosed herein can store data in database(s) and/or in other dataorganization structure(s).

Users of the system 10 can include patients and medical practitionersinvolved with treating one or more of the patients. In some embodiments,the system 10 can be accessible by users other than patients and medicalpractitioners, such as by medical administrators, e.g., billingadministrators, inventory controllers, etc. Different users can haveaccess to different portions of the system 10, as mentioned aboveregarding security features. For non-limiting example, the system 10 canbe configured to allow patients to access only the diagnosis andtreatment module 200 and the recovery module 208, to allow medicaladministrators to access only the operation module 204, and to allowsurgeons to access all of the modules 200, 202, 204, 206, 208. A usercan have access to only a portion of a module, e.g., to only a subset ofcomponent modules within any one or more of the modules 200, 202, 204,206, 208.

Diagnosis and Treatment Module

The diagnosis and treatment module 200 can generally provide users ofthe system 10 with an interface for managing patient wellness andprevention and for managing patient treatment at least until planningfor any surgery begins. More particularly, the diagnosis and treatmentmodule 200 can receive patient-specific data such as symptoms, providediagnoses based on the patient-specific data, suggest medicalpractitioners experienced with particular diagnoses, provideconservative treatment options (e.g., non-surgical treatments) forparticular diagnoses, provide coaching on reducing risk factors for painthrough lifestyle changes, and provide interventional therapy treatmentoptions (e.g., surgical treatments, needle procedures, biopsy, catheterbased procedures, etc.) and/or pharmacological treatments for particulardiagnoses. Indications of drugs and their potential interactions withexisting medications can also be provided. In this way, the diagnosisand treatment module 200 can be configured to assist patient diagnosisand treatment through a continuum including patient onset of pain,patient arrival at a doctor, and a decision to pursue an invasivetreatment such as surgery. In one embodiment, the diagnosis andtreatment module 200 can be implemented using one or more web pageswhich are configured to receive user input and present information to auser. In an exemplary embodiment, both patients and medicalpractitioners can access at least a portion of the diagnosis andtreatment module 200. In an exemplary embodiment, the diagnosis andtreatment module 200 can be accessed by users via a web interface, e.g.,by connecting to the Internet via a client terminal and accessing aspecific web address, by launching an app on a client terminal thataccesses the system 10, etc. As mentioned above, the users canwirelessly access the system 10, including the diagnosis and treatmentmodule 200.

The diagnosis and treatment module 200 can include a diagnosis module210, a treatment options module 212, a care provider module 214, and atreatment compliance module 216. Each of the modules 210, 212, 214, 216is discussed further below in turn.

As mentioned above, the diagnosis and treatment module 200 can beconfigured to read information from and write information to thediagnosis and treatment database 300. The diagnosis and treatmentdatabase 300 can include a diagnosis database 310, a treatment database312, and a care provider database 314. Various ones of the diagnosis andtreatment module's component modules 210, 212, 214, 216 can beconfigured to access one or more of the diagnosis database 310, thetreatment database 312, the care provider database 314, and/or variousother databases, e.g., the pre-op database 302, the operation database304, the post-op database 306, and the recovery database 308. Each ofthe databases 310, 312, 314 is discussed further below in connectionwith various ones of the diagnosis and treatment module's componentmodules 210, 212, 214, 216.

Diagnosis Module

The diagnosis module 210 can provide users of the system 10 with aninterface for entering and evaluating symptoms and for receivingpreliminary diagnoses based on the entered symptoms. The preliminarydiagnoses can also be based on any one or more of prior treatmentsreceived by the patient, on physical examination data (e.g., signsnoticed by a medical professional examining the patient), images of thepatient, laboratory test results for the patient, patient demographicdata, and/or on historical tests (e.g., genetic testing). Basingpreliminary diagnoses on symptoms in addition to one or more otherpatient-specific factors can allow the diagnosis module 210 to providemore customized and better informed preliminary diagnosis informationspecific to a particular patient. The diagnosis module 210 can beconfigured to allow patients to enter their own symptoms for evaluationand possible diagnosis and to allow medical professionals to entersymptoms for their patients for evaluation and possible diagnosis. Thediagnosis module 210 can also be configured to allow patients to enterpreviously received treatments for the symptoms, includingself-treatments (e.g., over the counter medicine, etc.) andprofessionally-provided treatments. Each patient can be uniquelyidentified in the system 10, e.g., by name, identification code, etc.,such that symptoms entered for a particular patient by the patient andby other user(s) can be stored in the diagnosis and treatment database300, e.g., in the diagnosis database 310, as being associated with thepatient. The patient's Electronic Medical Record (EMR) can be linked bytheir health care provider to the diagnosis and treatment database 300.The symptoms and historical treatments identified for a particularpatient can be accessed at any time in the future using the system 10,which can help facilitate continued treatment and evaluation of thepatient, e.g., by allowing severity of symptoms to be tracked over timeas the patient and/or other user(s) updates the system 10. Symptoms fora patient can be stored in the diagnosis and treatment database 300,e.g., in the diagnosis database 310, with a date and time stamp, whichcan facilitate the continued treatment and evaluation of the patient.Similarly, other data discussed herein as being related to a particularpatient can be stored in the diagnosis treatment database 300, thepre-op database 302, the operation database 304, the post-op database306, and the recovery database 308 as being associated with the patientand as having a date and time stamp. The patient's EMR, historicaltreatments, images, lab results, physical exam results, symptoms, etc.,to the extent they are provided to the system 10, can be compared toother patient data included in the diagnosis and treatment database 300to compile outcome predictions based on retrospective results fromtreatment results of patients with similar indications. This compilationcan allow medical care providers and patients to make more informedtreatment and procedural decisions.

The system 10 can allow users to submit symptoms in a variety of ways.Other patient-specific factors can be submitted to the system 10 similarto that discussed herein regarding submission of symptoms.Patient-specific factors can be submitted to the system 10 by a patientor other user, e.g., the patient's primary care physician, a labtechnician, etc. Additionally, the diagnosis module 210 and othermodules discussed herein can be configured to consider patient-specificfactors in making various determinations similar to that discussedherein regarding the modules' consideration of symptoms.

FIG. 5 illustrates one embodiment of symptom input to the system 10 by auser 24 via a client terminal in the form of a touch screen tablet 26.Although the touch screen tablet 26 is shown in the illustratedembodiment, the system 10 can allow for symptom selection in other ways,such as by other touch screen devices, by other client terminals, bymouse selection, by drop-down text menu, etc. The touch screen tablet 26shows an interface allowing user selection of area(s) of a body in whichsymptom(s) manifest, but symptom(s) and their locations in the body canbe identified and entered by a user in other ways, such as by text,pointer device selection (e.g., mouse clicking, touch via stylus pen,etc.), drop-down menu, etc. The diagnosis module 210 can be configuredto provide the user with a variety of symptoms for selection based onthe user's selected area(s) of the body in which symptom(s) manifest.The variety of symptoms can be stored in the diagnosis database 310 forselection based on a user's input and for display to the user. Fornon-limiting example, if a patient selects a hip area as having pain,the diagnosis module 210 can be configured to retrieve from thediagnosis database 310 one or more possible additional symptomsassociated with hip pain, e.g., swelling, pain during movement, painwhen stationary, stiffness following a period of inactivity, etc., thatthe user can further select to help better define the user's condition.

FIGS. 5A-5C illustrate one embodiment of a user interface 25 configuredto be provided on a client terminal and to allow user input of data tothe system 10. The user interface 25 relates to entry of input of dataregarding back and neck pain, but as mentioned above, data regarding anyone or more symptoms can be input into the system 10. As shown in FIG.5A, the user interface 25 can be configured to allow a user to selectone or more portions of a body on a body chart where pain is beingexperienced. The body chart can include a front view body chart 27 and aback view body chart 29, each body chart 27, 29 providing predeterminedareas that can be selected by the user. As shown in FIG. 5B, for eachselected body portion, the user can be prompted to indicate a level ofpain experienced in that selected body portion by using a sliding scale31 ranging from zero (near a smiling face graphic) indicating no pain toten (near a frowning face graphic) indicating extreme pain. Levels ofpain can be input in any number of other ways, such as by entering anumerical level of pain from zero to ten in a text entry field, etc. Thesliding scale 31 can be provided in a pop-up window, as shown in theillustrated embodiment, or can be a separate screen on the clientterminal. The user can also be prompted to answer one or more questionsabout their symptoms, as shown in FIG. 5C. Examples of questions includeidentification data (e.g., name, birthdate, age, medical record number,etc.), “How long have you had your symptoms?”, “Which one of thefollowing best describes the amount of pain you have experienced duringthe past six months?” (none, mild, moderate, moderate to severe,severe), “Which one of the following best describes the amount of painyou have experienced during the past one month?” (none, mild, moderate,moderate to severe, severe), “During the past six months have you been avery nervous person?” (no, a little, some, most of the time, all of thetime), “What is your current level of activity?” (bedridden, primarilyno activity, light labor and light sports, moderate labor and moderatesports, full activities without restriction), “How do you look inclothes?” (very good, good, fair, bad, very bad), “Do you experiencepain when at rest?”, “What is your current level of work/schoolactivity?”, “Does your pain limit what you do around the house?”, “Doesyour condition affect your personal relationships?” (no, slightly,mildly, moderately, severely), “Have you been a happy person in the pastsix months?”, “Would you have the same pain management again if you hadthe same condition?” (definitely yes, probably yes, not sure, probablynot, definitely not), etc. In an exemplary embodiment, the questions canhelp pinpoint location, quality, and duration of the symptoms;precipitating events or circumstances; exacerbating and relievingfactors; and any changes over time.

FIG. 6 illustrates another embodiment of symptom input to the system 10by the user 24 via electronic image collection by a client terminal inthe form of a mobile phone 28. The user 24 can launch an app on themobile phone 28 configured to electronically communicate with thediagnosis and treatment module 200, e.g., interface with the system 10via the network 12 using electronic signals transmitted wirelesslyand/or using wired connection(s). The app can be configured to capturedata, e.g., one or more still images and/or one or more videos,indicating one or more physical characteristics of the patient 24, e.g.,a range of motion of the patient 24, an amount of swelling, skindiscoloration, etc. The captured data can be saved in the diagnosisdatabase 310. The captured data can be helpful in evaluating symptomsinvolving, e.g., joint issues and back pain, and/or can be helpful intracking changes in the patient over time, e.g., scoliosis curveprogression can be monitored over time and/or predicted into the futureas pediatric patients grow. The mobile phone 28 can be stably situated,e.g., via phone stand 30, to help provide stable images to the system10. The diagnosis and treatment module 200 can be configured to promptthe user to collect specific images, e.g., one or more images of theuser from a certain angle, a video of the user performing a certaintask, a video of a user holding a certain position for a certain amountof time, etc. The prompt can be based on one or more factors, such aspreviously collected images of the patient (e.g., want to collect imagesover time with each image being from a same angle), preference of theuser's primary care physician (e.g., always urge video collection overstill image collection), the user's entered symptoms (e.g., ask the userto capture an image of the user attempting to touch their toes if backpain is submitted as a symptom), etc.

Although an app is used to collect data in the illustrated embodiment, aperson skilled in the art will appreciate that data can be captured inother ways and that devices other than mobile phones can be used tocollect the data with or without running an app. A person skilled in theart will appreciate that data can be captured in a variety of ways,e.g., using a camera (standalone or integrated into another device suchas a mobile phone or tablet); a video camera (standalone or integratedinto another device such as a mobile phone or tablet); one or moresensors (e.g., gyro, accelerometer, global position system (GPS), etc.)on a smartphone, in a skin patch (e.g., patches available from MC10 Inc.of Cambridge, Mass.), integrated into smart clothing, or in additionalsensing or monitoring devices that can connect to the client terminalvia wireless or wired connection, etc.; any of a variety of known motioncapture apps or motion capture software; etc.

In another embodiment, a user, e.g., a patient, can use a head-mountedneural mapping device, e.g., an accelerometer, under medical supervisionto collect and submit neural mapping data to the diagnosis database 210.Neural mapping data can be helpful in determining and quantizing painlevels of a patient. Over time, the neural mapping data and thepatient's self-described pain can help the system 10 learn objectivepain levels, e.g., normalize pain levels to allow a more objectiveevaluation of pain.

By being accessible over a network, the system 10 can allow users toenter symptom information to the diagnosis module 210 when a patient isremote from a medical setting (e.g., doctor's office, hospital, clinic,etc.) and when the patient is in a medical setting. Allowing a patientto submit their own symptoms to the system 10 can result in one or morebenefits. A patient can better determine whether and when it would beappropriate to see a medical professional because the system 10 canprovide a recommendation of whether and when to visit a medicalprofessional in person based on the patient's specific symptoms, therebysaving both the patient's and the medical professional's time. If andwhen a patient visits a medical professional, the medical professionalcan access the system 10 to evaluate the patient's symptoms even beforethe patient personally discusses their symptoms with the medicalprofessional, which can allow the medical professional to better focustheir in-person time with the patient, e.g., ask more informedquestions, be prepared to perform certain tests, etc. Having symptomsstored in the diagnosis and treatment database 300 can help prevent thepatient from forgetting to mention certain symptoms to a medicalprofessional in person and/or from forgetting particular onset and/ortiming of certain symptoms because the symptoms will already be loggedin the system 10. The medical professional can therefore be better ableto provide diagnosis and treatment information to the patient becausethe information can be based on a more complete and accurate picture ofthe patient's condition. The system 10 can capture transient symptoms,e.g., hives, spasms, etc., that may not manifest when the patient is ata doctor's office or otherwise in direct observation of a medicalprofessional. These captured transient symptoms, e.g., recorded andstored audio, video, and/or still image, can allow a medicalprofessional to more fully evaluate a patient's condition by being ableto directly observe the transient symptoms without having to rely solelyon a patient's memory and/or on a patient's unintentionally inaccurateand/or medically imprecise description of transient symptoms.

By allowing users other than the patient to submit symptoms to thesystem 10 for a patient, the system 10 can allow for symptoms to belogged that may be overlooked by a non-medically trained person as notbeing significant and/or can ensure a more complete record of symptoms.The system 10 can therefore have more complete knowledge of a patient'ssymptoms and thus better analyze a patient's condition so as to providea more accurate diagnosis and/or more effective treatment plan for thepatient. The system 10 can allow users of the system other than thepatient to link and/or upload previously collected patient data, e.g.,prior medical history, demographics information, etc., to the system 10,which can allow the system 10 to better analyze information regarding apatient because more data can be taken into account for variousanalyses. Exemplary embodiments of uploading data such as images aredescribed in more detail in U.S. patent application Ser. No. 13/603,452entitled “Systems And Methods For Surgical Support And Management” filedSep. 5, 2012, which is hereby incorporated by reference in its entirety.

The diagnosis module 210 can be configured to analyze symptoms enteredby a patient, determine at least one possible diagnosis based on theentered symptoms, and provide the at least one possible diagnosis to theuser, such as by causing a display screen (e.g., a screen of the samedevice the user used to enter the symptoms) to show a list of thediagnos(i/e)s. The possible diagnos(i/e)s can be provided to the userwith a caution that the diagnos(i/e)s are preliminary only and that auser must consult a doctor for a complete evaluation and diagnosis.

The diagnosis module 210 can be configured to analyze the symptoms for apatient entered by one or more users and determine the at least onepreliminary diagnosis in a variety of ways. In an exemplary embodiment,the diagnosis database 310 can include a plurality of possiblediagnoses, each of the possible diagnoses being associated with aplurality of symptoms. This diagnosis data can be organized in any way,such as in a table. The diagnosis module 210 can be configured tocompare user-entered symptoms with the plurality of possible diagnosesstored in the diagnosis database 310 and determine which of theplurality of possible diagnoses are associated with symptoms matchingthe user-entered symptoms. The diagnosis module 210 can be configured tocompare gathered neural mapping data for a patient with pain level dataabout the patient previously entered by another user, e.g., by thepatient, and/or with previously determined neural maps stored in thediagnosis database 310. The diagnosis module 210 can thus be configuredto learn an objective way to measure pain, and to create a painthermometer based on data from a plurality of patients, rather than relyon a particular patient's pain numbers. Additionally, as mentionedabove, the diagnosis module 210 can be configured to analyze any one ormore patient-specific factors in addition to symptoms in determining adiagnosis.

The diagnosis module 210 can be configured to determine a diagnosisbased on a patient's entered patient specific-factors matchingpredetermined attributes or criteria. Each of the diagnoses in thediagnosis database 310 can be associated with predetermined criteria.Each of the criteria can include a plurality of attributes such thateach of the diagnoses are associated with a combination of attributesthat define patients having that diagnosis. In other words, thepredetermined criteria can define patient-specific factors associatedwith a diagnosis such that if a patient's factors match the criteria,the diagnosis module 210 can identify that diagnosis for the patient.The predetermined criteria can also define patient-specific factors thatexclude a particular diagnosis such that if a patient has a factor thatmatches the exclusion factor included in the criteria, the diagnosismodule 210 can exclude that diagnosis for the patient. The predeterminedcriteria for a diagnosis can thus include inclusion criteria (e.g.,attributes associated with the diagnosis) and exclusion criteria (e.g.,attributes excluding the diagnosis). The diagnosis module 210 can beconfigured to provide a confidence level with a determined diagnosisbased on the patient's factors matching with the predetermined criteria.The confidence level can reflect a number of the predetermined criteriathat are matched for a particular patient. In an exemplary embodiment,the confidence level can be provided as a percentage of attributesmatched for a patient (e.g., 75% match, 95% match, 80% match, etc.)and/or as a number of attributes matched (e.g., 7 of 8 attributesmatched, 18 of 18 attributes matched, etc.). If a patient matches all adiagnosis's attributes, the diagnosis module 210 can be configured toindicate that the patient is a “perfect” match. Correspondingly, if apatient does matches most but not all a diagnosis's attributes, thediagnosis module 210 can be configured to indicate that the patient isnot a “perfect” match but is a “possible” match or, if more attributesare matched, a “likely” match.

The diagnosis module 210 may determine that the user's entered symptomsdo not match any of the stored plurality of possible diagnoses, e.g., noone of the plurality of possible diagnoses includes all of the user'sentered symptoms. In such a case, the diagnosis module 210 can beconfigured to inform the user that no matching diagnoses were locatedand/or the diagnosis module 210 can be configured to determine one ormore “best guess” diagnoses based on, e.g., which one or more of thestored possible diagnoses match a majority of the user's enteredsymptoms.

The diagnosis module 210 can therefore be configured as a preliminarydiagnosis mechanism that collects various patient data, can help informa patient of one or more possible causes of their symptoms, and can helpinform medical practitioner(s) treating the patient of possiblediagnoses to consider upon evaluation of the patient, either in personand/or upon review of the user's entered data. Thus, even before apatient visits a medical care practitioner in person, or even if apatient never visits a medical care practitioner in person, the patientcan receive information regarding their symptoms, which can facilitatespeedy treatment. The diagnosis module 210 can also help inform medicalpractitioners about conditions with which they have less familiaritywith, which can help train the medical practitioners, make their jobeasier, and provide better outcomes through instant education of themedical practitioners. The diagnosis module 210 can be configured todetermine and report differential diagnosis, with ranked appropriatediagnoses and confidence levels for each assigned diagnosis, which canhelp a medical professional make more informed decisions regardingpatient diagnosis and/or treatment. The diagnosis module 210 can beconfigured to capture a plurality of coexisting diagnosis, e.g.metastatic tumor and fracture, scoliosis and myelopathy, etc. Since thediagnosis module 210 can capture all ongoing treatments, therapies andmedicines to which the patient has been exposed, the potential fordangerous drug interaction or hazardous interactions with differenttherapies can be avoided through automated warnings provided by thesystem 10 to, e.g., a surgeon, nurse, pharmacist, and/or patient.

The diagnosis module 210 can allow a medical practitioner to manuallyenter diagnosis information for a patient to be stored in the diagnosisdatabase 310 for the patient. This manually entered diagnosisinformation can be based on symptom data input to the system 10 or canbe based on other data and analysis, e.g., data collected outside thesystem 10 and analyzed by the medical practitioner. By allowingdiagnosis information to be directly entered into the system 10, thesystem 10 can help manage treatment of the patient through a continuumof treatment following an initial diagnosis. The system 10 can thereforebe seamlessly integrated into a medical practitioner's current practice,a hospital setting, etc. in which at least some patients already havediagnoses for various illnesses, injuries, and diseases. Similarly, thesystem 10 can allow manual entry of other information mid-way through apatient's diagnosis and/or treatment, such as a patient's treatmentplan, so as to allow seamless integration of the system 10 into apatient's medical care.

By way of example, the system 10 can be used in a spinal context, suchas to test for the presence of cytokines (such as Fibronectin-aggrecancomplex, FAC) and growth factors (such as TNF-alpha or IL-8) in theintervertebral disc of patients, in specifically DDD or herniated disccases in the lumbar, thoracic, or cervical spine. The system 10 canprompt a physician to run this test as a result of the system's reviewof a patient's symptoms. The result of the test can be stored in thediagnosis database 310 and used in the diagnosis of the patient and inrecommending the use of certain treatments such as epidural steroidinjections, e.g., Enbrel or Remicade (TNF antagonists). As the system 10continually runs these tests on more patients, and then subsequentlytracks the test's validity in diagnosing the patient's condition byrelating it to the patient outcome of the chosen surgical treatments forDDD and/or herniated disc, the system 10 will gain a more refinedintelligence of when to prescribe the test, and when to prescribecertain medications and/or treatments (invasive or non-surgical) basedon the results of the test. The system 10 can also be configured toreceive the raw data of the test, and through the statistical powercreated by continually comparing these granular results with chosentreatments and patient outcomes, the system 10 can further refine theanalysis of the chemical components of the test and more accuratelyrelate them to diagnoses, treatments, and outcomes. Alternately, thesystem 10 can be configured to record the DNA data for each patient inthe diagnosis database 310, provided by a sequencing test, and run analgorithm that analyzes and compares the DNA markers for patients withsimilar pain diagnoses. Over time, this continual comparison will resultin the system 10 identifying markers that predict patients to be at ahigher risk for certain spinal disorders. This identification will helpin the initial diagnosis phase to develop an appropriate treatment planbased on the existence of these high-risk markers in combination withthe patient's symptoms. For example, if there are clear markers thatindicate that the condition will only worsen with time and that surgicalintervention will be necessary, then a less invasive surgery can be doneearly before the condition worsens and results in more pain anddisability. If the patient is lacking high risk markers, then a moreconservative treatment would be recommended as a first course of action.

For another example, the diagnosis module 210 can include an algorithm,alone or in combination with the treatment options module 212, that canbe configured to analyze inputs such as an MRI or CT scan of a patientso as to automatically detect specific features contained in inputs thatare related to specific pathologies. Based on the analysis, this autodiagnosis algorithm can provide feedback to the user of the pathologicissue that has been discovered for consideration in determiningdiagnosis, along with treatment recommendations, as determined inconcert with the other system inputs. In an exemplary embodiment, thealgorithm can have pre-programmed pathologies to look for, such ascollapsed disc space (shorter than a determined height) and a loss ofsignal in the spinal cord. These pre-programmed pathologies can haverelated treatment methods predefined in the diagnosis module 210 and/orthe treatment options module 212. As the system 10 collects more data,the system 10 can be able to compare these analyses and recommendationsto the functional outcomes across patients, and can learn how accuratepre-programmed inputs to the system 10 were, and adjust as necessary toincrease the accuracy of the auto diagnosis based on this result. Thesystem 10 can be configured to perform further analysis to autonomouslydevelop its own criteria for assessing the inputs (e.g., the MRI or CTscans) by using the data collected in the diagnosis and treatmentsdatabase 300 and/or the recovery database 308 to find common anomaliesbetween patients and the treatments that are most successful inaddressing them.

Treatment Options Module

The treatment options module 212 can provide users of the system 10 withan interface for receiving one or more treatment options based on thepreliminary one or more diagnoses determined by the diagnosis module210. A user can receive treatment option(s) for each of the determinedpreliminary diagnoses, or the treatment options 212 module can allow theuser to particularly select one or more of the preliminary diagnoses toreceive treatment option(s) therefor from the system 10.

The treatment options module 212 can determine the treatment option(s)in a variety of ways. In an exemplary embodiment, the treatment database312 can include a plurality of possible treatment options, each of thepossible treatment options being associated with at least one possiblediagnosis. This treatment options data can be organized in any way, suchas in a table. The treatment options module 212 can be configured toassemble composite patient data points in real time, until the searchcrosses a predetermined threshold for meeting an optimal constellationof findings that most perfectly match with a certain treatment option.The treatment options module 212 can be configured to screen for allknown contraindications and relative contraindications simultaneously.If key elements of these are found to be unknown, the treatment optionsmodule 212 can be configured to query the user to provide the missingdata before suggesting any treatment. The treatment options module 212can be configured to compare a possible diagnosis with the plurality oftreatment options stored in the treatment database 312 and determinewhich of the plurality of possible treatment options are associated withthe possible diagnosis based on prior treatments and outcomes that havebeen uploaded to and stored in the treatment database 312. Thiscomparison can be performed automatically by automatically reviewing thestored data. The information loaded to the system 10 regarding priorpatients can include a plurality of specific variables or attributes foreach patient and treatment type that can be compared and grouped innumerous combinations automatically by the system 10. Examples of thevariables include patient age, height, weight, pain levels, scan images(e.g., MRI, CT, x-ray, etc.), range of motion, lifestyle behaviors(e.g., smoking, exercise, etc.), bone density, disc degeneration, painlocations, type of procedure performed, bone removed, disc removed,implants used, pharmaceuticals administered, reduction in pain, returnto work, fusion rate, and functional outcome. Collection of the specificvariables for each patient can allow the system 10 to automatically andcontinually review the data and discover trends in the variables betweenpatients and relate these trends to patient type, procedure type, andfunctional outcomes. These relationships can be evaluated by the system10 through multiple algorithms in the diagnosis and treatment module 210to provide more accurate recommendations of treatments for the patientand their symptoms to result in an optimized outcome.

The treatment options module 212 can be configured to determine atreatment using predetermined criteria similar to that discussed aboveregarding the diagnosis module 210 using predetermined criteria todetermine a diagnosis.

The treatment options module 212 can be configured to cause a displayscreen (e.g., a screen of the same device the user used to enter thesymptoms) to show a list of the possible treatment option(s). Thepossible treatment option(s) can be provided to the user with a cautionthat the possible treatment option(s) are preliminary only and that auser must consult a doctor for a complete evaluation and treatment plan.The possible treatment option(s) can be provided to the user withhistoric success rates of each of the possible treatment option(s). Thehistoric success rates can be stored in the treatment database 312 foreach of the treatment options and can be manually entered. Alternativelyor in addition, the historic success rates can be based on datacollected by the system 10 regarding a plurality of patients, e.g.,HRQOL, health economic data, etc., such that the system 10 can act as afeedback loop system in which previously collected data regardingtreatments received by actual patients can inform treatment optionssuggested to future patients. The possible treatment option(s) can beprovided to the user with educational resources for at least one of theoptions, e.g., links to informational web pages stored in the system 10(e.g., in the treatment database 312), links to third party educationalwebsites, lists of or links to journal articles or books, educationalvideo of a surgical procedure that is stored in the system 10 (e.g., inthe treatment database 312), links to medical device product brochures(e.g., brochures stored electronically in the system 10), etc.

In some embodiments, the treatment options module 212 can provide codingand reimbursement information for each of the suggested treatmentoptions. Providing such information can facilitate educateddecision-making about which of the treatment options to pursue (if any).

In some embodiments, the treatment options module 212 can be configuredto consider one or more factors other than patient symptoms indetermining treatment option(s) to suggest for a patient. Consideringsuch factors can allow a potential success rate of various treatmentoptions to be considered by the treatment options module 212 insuggesting particular treatment options for a patient. Such factors caninclude any one or more of a patient's age, medical practitionertreatment preferences previously logged in the treatment database 312, apatient's bone density, a patient's medical history, prior surgeryperformed on the patient, discography, a compliance rate of the patientwith prior non-surgical treatments, leak rate studies, patient images(e.g., x-rays, magnetic resonance imaging (MRI) images, x-ray computedtomography (CT) scans, etc.), test results data from lab tests, etc.

FIG. 7 illustrates an embodiment of obtaining accurate bone densityinformation for a patient using a CT scanning machine 32 and a bonedensity marker 34. The bone density marker 34 can include a firstmaterial having a first density ρ₁ on one side, e.g., right side, of themarker 34 and a second material having a second density ρ₂ next to thefirst material on an opposite side, e.g., left side, of the marker 34.The marker 34 can be placed on and/or under a patient scanned by the CTmachine 32. By knowing the densities ρ₁, ρ₁ of the marker 34, acorrelation can be made to the grey scale output of the CT scan.Densities of any pixel in the CT scan can therefore be determined. Thepatient's bone density can therefore be determined by analyzing pixelsshowing bone in the CT scan. The treatment options database 210 can beconfigured to consider the patient's bone density data in determiningsuggested treatment options for the patient, e.g., suggest treatmentoptions with very low impact exercise if a patient has very low bonedensity, suggest no surgical treatments if bone density is too low, etc.

The possible treatment options suggested by the treatment options module212 can include non-surgical treatment options (e.g., diet adjustments,exercise regimens, medications, etc.) and invasive treatment optionssuch as surgical treatment (e.g., specific surgical procedures), needleprocedures, biopsy, and catheter based procedures. In an exemplaryembodiment, only non-surgical treatment(s) can be initially suggested toa user of the system 10. In this way, a conservative treatment can bepursued before a more radical, typically more costly treatment such assurgery is pursued. If one or more of the non-surgical treatments arepursued and are determined to unsatisfactorily address a patient'sproblem(s), then the treatment options module 212 can be configured tosuggest one or more invasive treatment options. The suggestion invasivetreatment options can each include procedure type and, if appropriate,implant options. The treatment options module 212 can be configured tosuggest the one or more invasive treatment options upon request by auser, e.g., when a medical practitioner requests non-conservativetreatment options for a particular patient, and/or can be configured tosuggest the one or more invasive treatment options when a trigger eventoccurs, e.g., after a predetermined threshold amount of time passes fromcommencement of a non-surgical treatment for a patient after which thepatient has not shown a predetermined amount of improvement. By way ofnon-limiting example, the treatment options module 212 can be configuredto analyze data gathered by the diagnosis module 210 and/or thetreatment compliance module 216, discussed further below, and determinewhether the patient's mobility has improved by a certain degree after acertain amount of time as indicated by reported pain levels and/oranalysis of captured images. Before the treatment options module 212suggests one or more invasive treatment options following determinationthat a non-surgical treatment is not achieving a desired outcome, thetreatment options module 212 can be configured to first suggest one ormore other non-surgical treatments.

By suggesting treatment option(s) to a user, the diagnosis and treatmentmodule 200 can allow the user to receive and analyze information thatmay be outside their area of medical expertise. For non-limitingexample, a general medical practitioner such as a patient's primary carephysician (PCP) may not be very familiar with specific spine injuries ordeformities. The diagnosis and treatment module 200 can allow the PCP toenter a patient's spinal symptoms (e.g., to the diagnosis module) andreceive a suggested treatment (e.g., from the treatment options module212) for the spine-related symptoms. The PCP can therefore providespeedier, more detailed diagnosis information to the patient, as well asdirect the patient to a specialist and/or advise appropriate care, morequickly, and likely more accurately, than if the PCP had to rely ontraditional diagnosis and treatment assistance tools such as print orelectronic books, print or electronic articles, and consultation withcolleagues. The PCP can still consult the traditional diagnosis andtreatment assistance tools. Additionally, the PCP can become betterinformed about spinal issues through use of the diagnosis and treatmentmodule 200 for the patient with spine-related symptoms, which can helpthe PCP train residents, educate colleagues, educate patients, and treatfuture patients having similar symptoms.

The treatment options module 212 can include a patient consent oftreatment form where password protected signature approval is obtainedfrom the patient noting a full understanding of options and agreement toprovider prescribed treatment(s). This form and signature can be storedin the patient record of the diagnosis and treatment database 300 andcan be linked to the patient's EMR.

Care Provider Module

The care provider module 214 can provide users of the system 10 with aninterface for receiving a recommendation of one or more medicalpractitioners to treat a patient based on one or more of the preliminaryone or more diagnoses determined by the diagnosis module 210, the one ormore treatment option(s) determined by the treatment options module 212,and the patient's geographic location. The care provider database 314can include data regarding a plurality of medical practitioners, each ofthe medical practitioners being associated with at least one geographiclocation, at least one area of medical practice, at least one previouslyperformed surgical procedure, and/or at least one previously providedmedical treatment. This care provider data can be organized in any way,such as in a table.

The care provider module 214 can be configured to compare at least oneof the preliminary diagnoses determined by the diagnosis module 210, thetreatment option(s) determined by the treatment options module 212, andthe patient's geographic location with the data stored in the careprovider database 314 to determine one or more medical practitionersassociated with the preliminary diagnoses determined by the diagnosismodule 210, the treatment option(s) determined by the treatment optionsmodule 212, and/or the patient's geographic location so as to beappropriate for the patient to consult for further medical informationand/or treatment. The care provider module 214 can be configured tocause a display screen (e.g., a screen of the same device the user usedto enter the symptoms) to show a list of the possible care provider(s).The list can include information regarding the care provider(s) such asname, address, gender, phone number, affiliated hospital, any acceptedinsurance plans, website, and/or area of medical specialty. The careprovider module 214 can be configured to provide access to outcomes foraffiliated hospitals and for physicians performing the potentialtreatments. The outcomes can be stored in the care provider database314. The outcomes can be provided for review by, e.g., the patient, thepatient's family, the patient's caregiver, the patient's primary carephysician, etc. The care provider module 214 can therefore assistpatients in locating a medical practitioner near the patient and/or withparticular skill related to the patient's possible diagnosis and/orpossible treatment.

Treatment Compliance Module

The treatment compliance module 216 can provide users of the system 10with an interface for tracking patient compliance with a treatment plan.The treatment plan can be one of the suggested treatment optionssuggested by the treatment options module 212, can be one of thesuggested treatment options suggested by the treatment options module212 as modified by a medical practitioner, or can be a treatment planentered into the system 10 by a medical practitioner without assistanceof the treatment options module 212. The treatment plan can be stored inthe treatment database 312. The treatment compliance module 216 can thusallow monitoring and management of a patient's treatment, which can helpthe patient's doctor evaluate the patient's progress and/or can helpdetermine whether and when modifications to the treatment plan may benecessary, such as by adjusting the treatment plan (e.g., changingdietary requirements, changing a frequency of doctor check-ups, etc.) orreplacing the treatment plan (e.g., a non-surgical treatment) withanother treatment plan (e.g., a surgical treatment).

Patients and users other than patients can submit data to the treatmentcompliance module 216 for storage in the treatment database 312. Datacan therefore be received by the treatment compliance module 216 whetherthe patient is or is not in a medical setting and can be receivedthroughout the patient's treatment, including times other than when thepatient visits or consults a medical practitioner. More accurate andmore timely data regarding treatment plan compliance can therefore begathered and analyzed.

Patient compliance response to medicinal treatments can be monitored,e.g., by a patient's treating physician, by viewing compliance datastored in the treatment database 312, which can allow dose level changesto be made more readily by, e.g., the treating physician. Simple at-homediagnostic tools can be used to monitor components within blood, urineor other fluids. This at-home diagnostic tool information can allows thepatient's physician to adjust medicinal dosages to the individualpatient. The treating physician can change the dose of the medicine tothe needs of the patient based upon the information tracked andrecorded. Other at home tools can be additionally or alternativelymonitored; such as results of self-administered ultrasound images,photographs of incision sites, microscopic photos of areas of concern,etc. These other at-home tools can be uploaded to the patient's recordin the treatment database 312, where the data can be accessed andreviewed by, e.g., the patient's surgeon.

Users can submit data to the treatment compliance module 216 similar tothat discussed above regarding submission of data to the diagnosismodule 210. Non-limiting examples of compliance data that can begathered by the treatment compliance module 216 include exerciseperformed, medication taken, daily diet, physical therapyattended/performed, physiological data such as heart rate, patientgeographic location, pain, neurologic tracking, bone alignment (e.g.,spine curvature, etc.), and patient movement (e.g., mobility, gait,walking speed, flexibility, muscular strength, posture, range of motion,joint movement, etc.). The treatment compliance module 216 can beconfigured to accept manual entry of compliance data by a user, e.g.,submission of types and lengths of physical therapy, and to acceptautomatically gathered compliance data, e.g., smartphone or braceletlocation and movement tracking data. The treatment compliance module 216can be configured to automatically gather data at predetermined timeintervals, e.g., every sixty minutes, every twenty-four hours, everySunday morning, etc., which can help allow for more accurate comparisonof data gathered at different times and/or on different days.Additionally or alternatively, the treatment compliance module 216 canbe configured to automatically gather data upon detection of a triggerevent, such as use of a pedometer, e.g., automatically gather pedometerdata when the patient walks/runs so as to increase the pedometer'scount. The treatment compliance module 216 can be configured to prompt auser for specific compliance data and/or prompt the user to entercompliance data at specific dates and/or times. The treatment compliancemodule 216 can be configured to allow for scanning of medications takenand patient compliance data acquisition at times correlated withmedication intervals, e.g. directly before, one hour after, two hoursafter, four hours after, eight hours after, etc.

The treatment compliance module 216 can be configured to analyzereceived compliance data to determine a compliance level and/or asuccess rate of the treatment overall and/or per symptom. The compliancelevel and/or the success rate can help a medical practitioner and/or thetreatment compliance module 216 determine whether modification of apatient's treatment plan is necessary.

The treatment compliance module 216 can be configured to comparereceived treatment compliance data for a patient with historiccompliance data for other patients who underwent similar treatment tohelp determine the effectiveness of the treatment for the patient. Thecomparison can allow the treatment compliance module 216 to determinewhether a patient is adequately following the treatment plan or islagging behind historical benchmarks achieved by other patientsundergoing the treatment. The comparison can also allow the treatmentoptions module 212 to evaluate treatment options for future patientsbecause if a treatment is historically shown to be problematic for anyone or more reasons (e.g., difficulty in achieving patient compliance,slow progress in addressing symptoms, expensive, lack of insurancepayments, etc.) or shown to be particularly effective for any one ormore reasons (e.g., patient mobility consistently increases,non-surgical treatment usually not followed by surgery, etc.), thetreatment options module 212 can be more likely (for particularlyeffective treatments) or less likely (for problematic treatments) torecommend the treatment for future patients.

Because the treatment compliance module 216 can be configured tosimultaneously and continuously receive information regarding multiplepatients, the diagnosis and treatment module 200 can continually analyzereceived data to help determine efficacy of a particular patient'streatment plan. The diagnosis and treatment module 200 can thusdetermine that a particular patient's treatment plan should be modifiedbased on another set of patients' data indicating low or higheffectiveness for a particular treatment aspect, such as a specificexercise performed daily. In other words, the diagnosis and treatmentmodule 200 can learn from other patients' experiences that the presentpatient's treatment could benefit from a modification, e.g., perform aspecific exercise once every other day instead of once daily, ceaseperformance of a particular exercise, decrease salt intake, wear a kneebrace 24/7 instead of only while sleeping, etc. The diagnosis andtreatment module 200 can be configured to suggest the modification ofthe patient's treatment plan to the patient's care provider, e.g., byproviding an alert (e.g., email message, text message, instant message,phone call, etc.) to the care provider indicating that modification ofthe patient's treatment plan is recommended. The care provider canreview the modification, e.g., by logging onto the system 10, anddetermine whether to modify the patient's treatment plan. Alternatively,the diagnosis and treatment module 200 can be configured toautomatically modify the patient's treatment plan and inform the patientvia an alert as to the modified treatment plan. Usually, however, a careprovider would review a modification to check its appropriateness forthe particular patient before the diagnosis and treatment module 200automatically modifies the patient's treatment plan and informs thepatient of the change.

The treatment compliance module 216 can be configured to providefeedback to the patient regarding their compliance, which can helpensure that a patient complies with the plan as much as possible and/orcan help show the patient that the plan is effectively treating thesymptom(s) or that the symptom(s) are not dissipating, in which case thepatient can be prompted to contact their care provider for consultation.The compliance feedback can be provided in a variety of ways.Non-limiting examples of compliance feedback include a percentageindicating degree of compliance with all plan aspects; a model of bonealignment over time; a graph of mobility over time; connection with orcomparison to other patients with similar symptoms, diagnoses, andtreatment plans as a way to compare progress and provide motivation tothe patient to comply with their treatment plan by being inspired by theprogress of others in their peer group; etc.

Pre-Op Module

The pre-op module 202 can generally provide users of the system 10 withan interface for planning surgery, e.g., doctor's office pre-opplanning, operating room (OR) pre-op planning, and patient pre-opplanning. More particularly, the pre-op module 202 can allow surgeons toelectronically perform three-dimensional (3D) simulated surgeries onvirtual models of patients to test surgical ease and/or potentialsurgical outcomes before actually performing the surgical procedure. Thesimulated surgeries can include variations of the same surgicalprocedure on a patient so as to try different surgical instrumentsand/or different surgical strategies. The pre-op module 202 can alsofacilitate logistical surgical planning such as equipment ordering andsupply, OR scheduling, and personnel scheduling. The pre-op module 202can also facilitate the logistics of preparing the patient for surgery,such as by managing patient pre-op requirements and activities beforeand after the patient arrives at the hospital. In this way, the pre-opmodule 202 can be configured to assist pre-op planning and managementthrough a continuum from a decision to pursue surgery to the patient'sarrival at an OR for surgery. In one embodiment, the pre-op module 202can be implemented using one or more web pages which are configured toreceive user input and present information to a user. In an exemplaryembodiment, both patients and medical practitioners can access at leasta portion of the pre-op module 202.

The pre-op module 202 can include a surgical procedure module 218, anequipment management module 220, a scheduling module 222, and a patientpreparation module 224. Each of the modules 218, 220, 222, 224 isdiscussed further below in turn.

As mentioned above, the pre-op module 202 can be configured to readinformation from and to write information to the pre-op database 302.The pre-op database 302 can include a procedure database 316, aninventory database 317, and a catalog database 318. Various ones of thepre-op module's component modules 218, 220, 222, 224 can be configuredto access one or more of the procedure database 316, the inventorydatabase 317, the catalog database 318, and/or various other databases,e.g., the diagnosis and treatment database 300, the operation database304, the post-op database 306, and the recovery database 308. Each ofthe databases 316, 317, 318 is discussed further below in connectionwith various ones of the pre-op module's component modules 218, 220,222, 224.

Surgical Procedure Planning Module

The surgical procedure planning (SPP) module 218 can provide users ofthe system 10 with an interface for electronically performing 3Dsimulated surgeries. In an exemplary embodiment, only surgeonsauthorized to perform surgery can access the SPP module 218. Theprocedure database 316 can be configured to store a record of aperformed simulated surgery, e.g., a video of the simulated surgery, aninventory of surgical instruments used in the simulated surgery,statistics regarding the simulated surgery (e.g., a total length ofsurgery time, a length of a particular portion of the procedure, anamount and/or exact location of bone and/or soft tissue removed from thevirtual patient, etc.), annotations or notes added by the userperforming the simulated surgery, etc. The simulated surgery cantherefore be used in the future for reference and/or analysis by theperformer of the simulated surgery, by residents for training purposes,by staff involved with an actual surgical procedure corresponding to thesimulated surgery, and/or by other users of the system 10, such asduring and/or after performance of an actual surgical procedurecorresponding to the simulated surgical procedure, as discussed furtherbelow regarding the operation module 204 and the post-op module 206.

The SPP module 218 can allow a user to select a surgical procedure tosimulate. The user can simulate any number of surgical procedures,thereby allowing the user to experiment with procedures that the usermay never have performed before or may only rarely perform. Theprocedure database 302 can include a collection of surgical proceduresfrom which the user can select the surgical procedure. The proceduredatabase 302 can include data related to each of surgical procedures inthe collection, which can allow the SPP module 218 to providesuggestions and options to the user based on the user's selection of aparticular surgical procedure. The SPP module 218 can be configured torecommend an optimized plan for the selected surgical procedure. In anexemplary embodiment, the optimized plan can be provided to the userbefore commencement of the simulated surgery and can be accessible bythe user throughout performance of the simulated surgery. The SPP module218 can be configured to develop the optimized plan based on a pluralityof factors, e.g., data stored in the procedure database 316 (and/or inany other database) regarding previously performed actual surgicalprocedures and outcomes corresponding to the selected surgical procedureperformed by the user and/or other users, data regarding the patient onwhich the simulated surgery will be actually performed, one or moregoals identified by the user as being a surgical outcome goal, etc.

By way of non-limiting example, the SPP module 218 can be configured toprovide a menu of surgical instruments to the user customized to thesurgical procedure selected by the user (e.g., a menu including surgicalinstruments used in actual surgical procedures of a same type as theselected simulated procedure previously performed by the user and/orother users in the past), an estimated cost of the selected surgicalprocedure based on previously performed actual surgical procedures of asame type as the selected simulated procedure, one or more professionaleducational resources about the selected simulated surgical procedure(e.g., links to external websites; an estimated costs of the selectedsurgical procedure for each different equipment and/or staff selectionmade by the user; links to manuals, videos, images, and/or otherinformational data stored in the catalog database 318; andidentification of colleagues of the user (e.g., surgeons working in thesame hospital as the user) who have previously performed an actualsurgical procedure of a same type as the selected simulated procedureand are available for consultation; etc.); identification of surgicalsupport staff associated with the user (e.g., staff working in the samehospital as the user) who have assisted with an actual surgicalprocedure of a same type as the selected simulated procedure. Exemplaryembodiments of providing educational support to users are described inmore detail in U.S. patent application Ser. No. 13/603,452 entitled“Systems And Methods For Surgical Support And Management” filed Sep. 5,2012.

The SPP module 218 can be configured to allow a user to save a selectedlist of surgical instruments, implants, and/or auxiliary equipmentincluding hardware (e.g., monitors, scope, fluoro, etc.), anddisposables (e.g., tubing, drapes, sensors, sharps, etc.) in theprocedure database 316 that can be displayed to the user each time theuser decides to perform a simulated surgery of a selected type or of anytype. In some embodiments, a selected list of surgical instruments inthe procedure database 316 can be saved for use by a plurality of users,e.g., users who all work at the same hospital, which can help ensurethat only instruments actually available for use by surgeons at thehospital are selected for use in a simulation. Any lists saved in theprocedure database 316 can be modified or deleted at any time.

The SPP module 218 can be configured to suggest one or more alternates sfor one or more selections by the user for use in the selected surgicalprocedure. Using surgical instruments as an example, the suggestedalternate(s) can be instrument(s) similar to the selected instrument asdetermined by previous correlations made between different surgicalinstruments, e.g., categorizing each surgical instrument by type, size,which actual surgical procedures the instrument was previously used inby the user and/or other users, etc. The suggested alternate(s) may bepreviously unused or unknown to the user. The user can thus be informedof newly available instruments, of instruments that may make theprocedure easier to perform, and of instruments that may be less costlythan the selected instrument. The inventory database 317 can store data(e.g., a table) regarding a plurality of actual surgical instrumentsavailable for use by the user in an actual surgery. The suggested one ormore alternate surgical instruments can be based on the actualavailability of instruments as indicated in the inventory database 317.

FIG. 8 illustrates an embodiment of a menu including surgicalinstruments and implants 36 used in actual surgical procedures of a sametype as the selected simulated procedure that the SPP module 218 candisplay to a user 38. A client terminal on which the menu is displayedand on which the simulated procedure can be performed by the user 38 isshown in the illustrated embodiment as a tablet 40, but as mentionedabove, any client terminal can be used to access the system 10. Each ofthe surgical instruments and implants 36 can be a 3D model of an actualsurgical instrument available for use in an actual surgical procedure.Information about each of the instruments and implants 36 can be shownon the display and/or available by selecting one of the instruments andimplants 36, e.g., by clicking on or hovering a selection tool over aninstrument. The instrument information can be stored in the catalogdatabase 318. Non-limiting examples of information about instruments,implants, and auxiliary equipment include cost, size, availability inthe user's hospital inventory, manufacturer, indication as to whetherthe user previously used the instrument in a previous actual surgicalprocedure, and whether additional views of the instrument are available.Although the menu is shown in FIG. 8 as a pictorial menu, the menu canbe presented in any way, such as all text, all pictorial, or acombination of text and images. Additionally, one or more informationalresources, e.g., links to product brochures, links to educational videosof products in use, identification of previous surgical procedure(s)using the menu item that were performed by the user, etc., can beprovided for any one or more of the menu items.

The SPP module 218 can be configured to model the patient on which theselected simulated surgical procedure is to be performed. In otherwords, the SPP module 218 can be configured to create a virtual patientmodeled on an actual patient. The virtual patient can be based on datastored in the system 10 (such as data regarding the actual patientstored in the diagnosis and treatment database 300, e.g., patientweight, x-ray images, CT images, MRI images, ultrasound images, BMI,genetic test results, visual images of the patient, etc.) and/or basedon typical patient data stored in the system 10. The simulated surgerycan thus be performed on a model as close to the actual patient aspossible, helping to allow the simulation to train the user as much aspossible and helping to provide reliable outcomes of the surgery.

FIG. 9 illustrates an embodiment of a simulated surgical proceduredisplay 42. A vertebra is circled in the display 42 for ease ofidentification of a surgical target 44.

A simulated surgical procedure display can include one or more useroptions configured to provide enhanced visualization of the procedure.Non-limiting examples of such options include 3D (e.g., the user canchoose 3D display and wear 3D glasses to properly see the 3D display),holograms, and topographical maps. FIG. 10 illustrates an embodiment ofa topographical mapping system 46 including a pin table 48 configured tofacilitate visualization of 3D data on a 2D display device 50. The pintable 48 can include a plurality of pins 48 a each configured toautomatically adjust in height to show 3D data based on the 3D model ofthe patient in the SPP module 218, thereby allowing, e.g., visualizationof the deformity and correction. The pins 48 a can be covered in aflexible sheet to enhance visualization of the preoperative, intra, andpost operative 3D geometry.

The simulated surgery can allow the user to simulate the selectedsurgical procedure from beginning to end. Aspects of the selectedsurgical procedure that can be simulated can include one or more of anaccess point on the patient, surgical instruments used in the procedure,a path through and/or retraction of tissue and nervous structures, boneremoval, soft tissue removal, tissue and structure movement, correction,movement due to indirect decompression, and placement of all implants.The user can save the simulated procedures at various points throughoutthe simulation, which can allow the user to repeat aspects of theprocedure more than once to perfect technique, to test performance ofdifferent surgical products, to test the suitability of different accesspoints, and/or to achieve other goals.

The SPP module 218 can be configured to analyze various aspects of thesimulated surgical procedure in real time with performance of thesimulation. For non-limiting example, the SPP module 218 can beconfigured to monitor an amount of radiation the patient, surgeon, andOR staff could be exposed to during the surgery and, optionally, tally acumulative total radiation exposure for the patient including thesimulated surgery and actual prior radiation exposure as well as futurepredicted exposures. Monitoring radiation exposure can help encouragereduction of the patient's radiation exposure and help ensure that thepatient is not exposed to radiation beyond an acceptable level within acertain period of time. For non-limiting example, the SPP module 218 canbe configured to compare drug use during the simulated procedure withknown allergies of the patient and with known drug interactions, therebyhelping to reduce chances of drugs adversely affecting the patientduring or after surgery. For yet another non-limiting example, the SPPmodule 218 can be configured to perform predictive volumetric modelingof soft tissue movement, stretch, removal (e.g., of a herniated disc),and change based on each step of the simulated procedure. The user canthus be able to see in real time with the simulation how tissue andother structures will move based on each step of the procedure. Duringthe simulated procedure, the SPP module 218 can be configured to usethis predictive modeling to show where tissue and other structures arepredicted to be, allowing for navigation around them. The SPP modulesimulation can utilize historical surgical and literature data topredict neural responses and/or changes based upon a predicted amount ofretraction and/or decompression preformed. When the simulation iscomplete, the SPP module 218 can be configured to analyze the procedurefor projected results, e.g., potential healing, potential increase inpatient mobility after “X” amount of time, amount of correction, etc.The user can thus consult the projected results and decide whether torevise the surgery, such as if the projected results are less than theuser would like and/or expect.

The SPP module 218 can facilitate the planning of revision surgeries.Using a spinal surgical procedure as an example, patient informationregarding initial implant product, position, bony ingrowth or ongrowth,etc. can be reviewed prior to surgery. The approach to remove theinitial implant, the optimal sizing of the replacement implant, and theneed for additional instrumentation (e.g., instrument set of the initialproduct or bone removal tools) can be incorporated in the surgical planfor the implant revision.

When the user completes a simulated surgical procedure, the user canmark the procedure as being complete. Marking the simulation as beingcomplete can signal to the SPP module 218 that pre-op planning by thesystem 10 for an actual surgical procedure corresponding to thesimulated surgical procedure can begin. Throughout performance of thesimulated surgical procedure, the SPP module 218 can allow the user tosave progress of the simulation, but these saves can be marked asincomplete simulations in the procedure database 316. The user canchoose to perform a simulation all at once, or the user can save apartially complete simulation and resume the saved simulation at a laterdate/time. A user can choose to never complete a partially finishedsimulation. The SPP module 218 can be configured to incorporatehistorical patient growth data to further depict structural changes overpatient's lifetime. This incorporation can be especially helpful withpatients having variable and changing anatomies, e.g., young scoliosispatients with variable and changing curvatures. Users of the system 10can run a predicted life changes module to assess potential futurechanges and assist in planning and refining the surgical procedure.

The SPP module 218 can be available to users inside and outside the OR.In other words, a user can perform a simulation using the SPP module 218outside the OR, e.g., before surgery is even scheduled, and/or insidethe OR, e.g., as immediate prep before a scheduled surgery. FIG. 11illustrates an embodiment of a user 52 accessing the system 10 in an ORvia a client terminal in the form of a computer including a processor(not shown), a display screen 54, and a keyboard 56. In the illustratedembodiment, the user 52 is simulating performance of a spinal procedure,but as mentioned above, the system 10 can be used to simulate othertypes of surgical procedures.

Equipment Management Module

The equipment management module 220 can provide users of the system 10with an interface for managing equipment used in surgery, such assurgical implants and surgical instruments. In an exemplary embodiment,only medical administrators (e.g., hospital inventory managers, etc.)and medical personnel (e.g., surgeons authorized to perform surgery,etc.) can access the equipment management module 220.

The equipment management module 220 can be configured to determinewhether actual inventory as reflected in the inventory database 317 canmeet the needs of actual surgery based on the completed simulatedsurgery (e.g., a simulation marked as complete). In alternative (e.g.,if no simulated surgery has been performed) or in addition to basing thedetermination on the completed simulated surgery, the equipmentmanagement module 220 can be configured to determine whether actualinventory as reflected in the inventory database 317 can meet the needsof actual surgery based on typical requirements for the selectedsurgical procedure and/or on specific requirements input by a user forthe surgical procedure, e.g., a surgeon's preference to use medicaldevices manufactured by a specific company. The equipment managementmodule 220 can be configured to compare virtual surgical instrumentsused by a user in a completed simulated surgery with actual surgicalinstruments available for use by the user in an actual surgicalprocedure corresponding to the simulation. As mentioned above, theinventory database 317 can store data regarding a plurality of actualsurgical instruments available for use in actual surgeries. Theequipment management module 220 can determine whether each of thevirtual surgical instruments used in the completed simulated surgery isavailable in actual inventory as indicated in the inventory database317. The SPP module 218 can be configured to allow a user to indicatethat one or more extra surgical instruments need to be available in anOR during performance of an actual surgical procedure corresponding to asimulated surgical procedure, e.g., an additional implantable screw, aplurality of additional sutures, etc. The equipment management module220 can be configured to include these requested extra surgicalinstruments in its determination of available actual inventory.

The equipment management module 220 can be configured to reserve actualsurgical instruments and actual auxiliary equipment in inventory for usein the actual surgical procedure by marking the actual surgicalinstruments corresponding to the used virtual surgical instruments, theactual auxiliary equipment corresponding to the used virtual auxiliaryequipment, and the requested extra surgical instruments as “reserved” inthe inventory database 317. Inventory available to the user, e.g.,inventory of a hospital, can thus be kept up to date for upcomingsurgeries performed by the user and by any other medical professionalsworking from the same inventory as the user.

The equipment management module 220 can be configured to order actualsurgical instruments and auxiliary equipment (e.g., from a medicaldevice distributor or a medical device company) for use in the actualsurgical procedure if the actual surgical instruments or actualauxiliary equipment are not available in inventory as indicated by theinventory database 317. The equipment management module 220 can beconfigured to order custom implants (e.g., from a medical devicecompany) that are manufactured for use with a specific patient. Anypre-configuration of surgical supplies such as surgical instruments(e.g., contouring of spinal rods in accordance with the pre-op plan) andgraft material (e.g., volume and type of a specific graft material) canbe ordered by the equipment management module 220. As will beappreciated by a person skilled in the art, custom implants can bedesigned and ordered in a variety of ways. For non-limiting example,methods and apparatuses for customizing an intervertebral implantincluding an initial step of obtaining a 3D anatomy are described infurther detail in U.S. application Ser. No. 11/150,468 (published asU.S. Pat. Pub. No. 2006/0282020) entitled “Customizing An IntervertebralImplant” filed Jun. 13, 2005. Generally, pre-op 3D anatomy of a patientcan be obtained in a variety of ways, e.g., using a CT scanning machine,and can be stored in the system 10, e.g., in the diagnosis database 310as discussed further below. The 3D image(s), e.g., a plurality of imagesfrom different angles, can be subsequently evaluated at any time by asurgeon or other medical staff to determine an appropriate customimplant for the patient, which can then be ordered for availabilityduring surgery.

The equipment management module 220 can also be configured to track thestatus of open orders for actual surgical instruments, for customimplants, and for pre-configuration. The equipment management module 220can thus help ensure that instruments are available when needed forsurgery and that surgery need not be rescheduled and/or delayed merelydue to surgical tools being unavailable. Exemplary embodiments ofordering and managing inventory are described in more detail in U.S.patent application Ser. No. 13/603,452 entitled “Systems And Methods ForSurgical Support And Management” filed Sep. 5, 2012.

Scheduling Module

The scheduling module 222 can provide users of the system 10 with aninterface for managing personnel (e.g., surgical support staff, salesrepresentatives, etc.) and hospital space used in relation to thesurgery (e.g., an OR, a patient prep room, a patient hospital recoveryroom, etc.). In an exemplary embodiment, only medical administrators(e.g., hospital inventory managers, etc.) and medical personnel (e.g.,surgeons authorized to perform surgery, etc.) can access the schedulingmodule 222.

The scheduling module 222 can be configured to determine whetheravailable personnel and available hospital space as reflected in theinventory database 317 can meet the needs of actual surgery based on thecompleted simulated surgery (e.g., a simulation marked as complete). Inalternative (e.g., if no simulated surgery has been performed) or inaddition to basing the determination on the completed simulated surgery,the scheduling module 222 can be configured to determine whether actualinventory as reflected in the inventory database 317 can meet the needsof actual surgery based on typical requirements for the selectedsurgical procedure and/or on specific requirements input by a user forthe surgical procedure, e.g., a surgeon's preference to work withspecific support personnel. The scheduling module 222 can be configuredto determine if available inventory has been autoclaved and sterile. Thescheduling module 222 can determine whether each of the hospital roomsneeded for the surgery (e.g., an OR, a prep room, a patient recoveryroom, etc.) are available in actual inventory as indicated in theinventory database 317, and/or the scheduling module 222 can determinewhether each of the surgical staff members needed for the surgery (e.g.,a sales representative, an anesthesiologist, etc.) are available inactual inventory as indicated in the inventory database 317. The SPPmodule 218 can be configured to allow a user to indicate specifichospital space and/or personnel preferences for performance of an actualsurgical procedure. The scheduling module 222 can be configured toinclude these specific preferences in its determination of availableactual inventory. The SPP module 218 can be configured to store a user'spreferences so the user does not have to repeatedly enter the samepreferences.

The scheduling module 222 can be configured to reserve one or morehospital spaces (e.g., rooms) for use in the actual surgical procedureby marking the hospital spaces as “reserved” for a specific date andtime in the inventory database 317. Similarly, the scheduling module 222can be configured to schedule one or more medical staff members to bepresent for the actual surgical procedure by marking the one or moremedical staff member's schedule (e.g., in one or more electroniccalendars accessible to the medical staff members) as being “reserved”for a specific date and time in the inventory database 317. Hospitalspace and personnel available to the user can thus be kept up to datefor upcoming surgeries performed by the user and by any other medicalprofessionals working from the same hospital space and/or personnel poolas the user.

Exemplary embodiments of scheduling personnel and hospital space aredescribed in more detail in U.S. patent application Ser. No. 13/603,452entitled “Systems And Methods For Surgical Support And Management” filedSep. 5, 2012.

Patient Preparation Module

The patient preparation module 224 can provide users of the system 10with an interface for preparing a patient for a scheduled surgicalprocedure. The patient preparation module 224 can prepare the patientthrough a continuum of at-home patient preparation to arrival at the ORfor the surgical procedure. In this way, the patient preparation module224 can help the patient prepare at home for the surgery so the patientis more likely to arrive at the hospital on time and with any necessarypre-surgery requirements met, and can help ensure that the patient isappropriately prepared for the surgery while at the hospital prior tothe patient's arrival at the OR.

The patient preparation module 224 can be configured to provide at-home,pre-surgery patient preparation to a user, e.g., to a patient scheduledfor surgery. In an exemplary embodiment, the patient preparation module224 can be configured to provide at least one reminder to the userregarding any pre-surgery requirements, such as a start day and time forfasting, day(s) and time(s) to ingest particular medication(s), day andtime to arrive at the hospital, any preoperative blood test which mustbe completed, bodily samples taken, etc. The reminder(s) can be providedto the user in any number of ways, as will be appreciated by a personskilled in the art, such as by email, phone call, a mobile device app,etc. The patient preparation module 224 can be configured to allow theuser to select one or more modes of reminder delivery. In an exemplaryembodiment, the system 10 can prompt the user to select one or moremodes of reminder delivery when the user initially establishes anaccount with the system 10, such as by prompting the user to enter atleast one of an email address, a home phone number, a mobile phonenumber, an instant message account, etc. to which the system 10 canprovide reminders, notifications, alerts, etc. If the user used thesystem 10 during treatment, the user can receive surgery prep remindersin the same way the user received treatment reminders, e.g., alerts fromthe treatment compliance module 216. In this way, by the time the useris preparing for a scheduled surgery, use of the system 10 can befamiliar to the user, which can help ease the stress of surgery and helpensure that the patient is appropriately informed and reminded of anynecessary pre-surgery procedures to be undertaken by the patient whenmedical personnel may not necessarily be with the patient to provideguidance.

The patient preparation module 224 can be configured to providepre-surgery patient support by monitoring a patient scheduled forsurgery from when the patient arrives at the hospital to when thepatient arrives at the OR for the surgery. In an exemplary embodiment,the patient preparation module 224 can be configured to monitor thepatient. The patient can be monitored in a variety of ways, such as by asmart chip embedded in a bracelet, necklace, gown, ID tag, etc. that thepatient can wear. The patient preparation module 224 can be configuredto monitor the patient's vital signs, location in the hospital, andstatus. This monitored information can allow the patient preparationmodule 224 to, e.g., trigger preparation of a room for the patient(e.g., using the patient's current location to trigger preparation of anext room for the patient), to alert medical personnel if the patientrequires immediate attention (e.g., due to change in vital signs), andto allow for scheduling and/or inventory adjustments in the inventorydatabase 317 if the patient's surgery is determined to be delayed basedon the patient's presence in a certain location a certain amount of timebefore a scheduled surgery start time. This monitored information canallow the patient preparation module 224 to perform an automated pre-opcheck to ensure that the surgery to be performed matches the plannedsurgery, e.g., surgery on the correct side or correct spinal level(s).The monitoring performed by the patient preparation module 224 can becontinued intra-operatively as needed to record vital signs, and can becombined with a multitude of other monitors that are conventionally usedin an OR. All of these outputs can be collected by the operationdatabase 304 of the system 10 throughout the procedure in order to beadded to the patient's record for inclusion in analysis.

Operation Module

The operation module 204 can generally provide users of the system 10with an interface for enhancing performance of a surgical procedure inan OR (or other location) and for gathering data for future analysis.More particularly, the operation module 204 can allow surgeons toconsult a 3D simulated surgery performed and saved via the pre-op module202, which can help an actual surgical procedure efficiently andeffectively achieve predetermined outcomes. The operation module 204 canprovide feedback regarding performance of the actual surgical procedureversus the previous simulated surgical procedure during performance ofthe actual surgical procedure, which can allow for mid-coursecorrections and/or can help inform surgical staff of their surgicalduties. The operation module 204 can also provide informationalmaterials during performance of the surgical procedure, such asinstrument use manuals or videos, which can help ensure that thesurgical procedure is performed properly. The operation module 204 canalso track various aspects of the surgical procedure, e.g., instrumentuse, personnel activity, patient radiation exposure without the patienthaving to wear a radiation monitoring device such as a dosimeter,patient vital signs, etc., which can allow for mid-course corrections,help inform surgical staff of their surgical duties, and/or facilitatepost-op analysis of the surgical procedure by the post-op module 206, asdiscussed further below. The information tracked by the operation module204 can also be used by the system 10, e.g., by the recovery module 208,to facilitate patient recovery and continued treatment post-surgery, asdiscussed further below. The information tracked by the operation module204 can also be used by the system 10, e.g., by the diagnosis andtreatment module 200 and/or the pre-op module 202, in recommendingand/or planning future surgeries involving the patient and/or otherpatients in circumstances similar to the patient on which the surgicalprocedure was performed. In this way, the system 10 can become smarterover time in various ways, such as by analyzing and recommendingeffective treatments in view of historical surgical outcomes, byproviding recommended surgical strategies in view of a particularsurgeon's historical performance in certain types of surgeries and/orwith certain types of surgical instruments, and/or by providingrecommended surgical strategies in view of multiple different surgeons'historical performance in certain types of surgeries and/or with certaintypes of surgical instruments.

In one embodiment, the operation module 204 can be implemented using oneor more web pages which are configured to receive user input and presentinformation to a user. In an exemplary embodiment, medical practitionerscan access at least a portion of the operation module 204 while patientscannot access the operation module 204 at all.

The operation module 204 can include a plan tracking module 226, aprocedure analysis module 230, an education module 228, an equipmenttracking module 232, an OR analysis module 234, and a personnel trackingmodule 236. Each of the modules 226, 228 230, 232, 234, 236 is discussedfurther below in turn.

As mentioned above, the operation module 204 can be configured to readinformation from and to write information to the operation database 304.The operation database 304 can include a products and proceduresdatabase 320, an OR database 322, an equipment database 324, and anethnography database 326. Various ones of the operation module'scomponent modules 226, 228 230, 232, 234, 236 can be configured toaccess one or more of the products and procedures database 320, the ORdatabase 322, the equipment database 324, the ethnography database 326,and/or various other databases, e.g., the diagnosis and treatmentdatabase 300, the pre-op database 302, the post-op database 306, and therecovery database 308. Each of the databases 320, 322, 324, 326 isdiscussed further below in connection with various ones of the pre-opmodule's component modules 226, 228 230, 232, 234, 236.

In an exemplary embodiment, an OR has a single user interface configuredto display information from the system 10 for consultation during asurgical procedure performed in the OR. The user interface can belocated in the OR, or can be in a nearby area visible from the OR. FIG.12 illustrates an embodiment of an OR setting in which the system 10 canbe accessed via a client terminal in the form of a computer including aprocessor (not shown), a display screen 58, and a keyboard 60. In theillustrated embodiment, a surgeon 62 and medical support personnel 64can all view the display screen 58, which can help all OR personneltrack the procedure, be better informed of their duties, and helpquickly notice any anomalies. FIG. 13 illustrates another embodiment ofan OR setting in which the system 10 can be accessed via a clientterminal in the form of a computer including a processor (not shown) anda display screen 66 located at a position easily seen from all or nearlyall positions within the OR by a surgeon 68 and medical supportpersonnel 70.

Various types of data gathered and/or analyzed by the system 10 can bedisplayed on a user interface and/or otherwise made available to medicalpersonnel in the OR, such as by other visual indicator (e.g., byblinking light on a surgical instrument, etc.), motion (e.g., byvibration of a surgical instrument, etc.), or sound (e.g., by audio beepfrom a speaker in communication with the system 10, etc.). By providingnon-auditory feedback alone or in combination with visual feedback, thefeedback can be less likely to be lost or overlooked in a noisy ORenvironment.

FIGS. 14-16 illustrate embodiments of various types of data that can beselectively displayed on a user interface accessible in the OR. FIG. 14illustrates a user interface 76 showing data indicating a progress ofthe surgery as gathered by the system 10 including a running total casetime (e.g., a continually updated time length of the surgery), a totalamount of patient blood loss, and a running total amount of spinal discremoval (e.g., a continually updated amount of spinal disc removed fromthe patient during the surgery). The progress data can help the surgerystay on schedule, help ensure safety of the patient (e.g., byconsidering whether the patient's blood loss reaches an unsafe level),and help the surgery meet its goals (e.g., by considering whether adesired amount of tissue is removed from the patient). Other,non-limiting examples of data indicating a progress of the surgery asgathered by the system 10 include an amount of bone removed from thepatient, an amount of tissue and/or bone needed to be removed for graft(e.g., as indicated in a pre-op plan), endplate preparation (e.g.,through endoscopic view and/or smart tools), implant placement (e.g.,computer guided rod contouring in-situ), an amount of correctionachieved, and pain/health of nerves. FIG. 15 illustrates a userinterface 78 showing data indicating patient information, therebyhelping to ensure patient safety. The patient information includespatient vital signs in the illustrated embodiment. Other, non-limitingexamples of patient information that the system 10 can be configured todisplay in the OR include pre-op patient images (e.g., x-rays, CT scans,etc.). FIG. 16 illustrates a user interface 80 showing instrumentinformation in the form of a list of instruments used in the surgicalprocedure and a running total amount of time each of the instruments hasbeen used in the surgical procedure. Other, non-limiting examples ofinstrument information that the system 10 can be configured to displayin the OR include camera views of one or more instruments, instrumentnavigation, and instrument specifications and/or manuals stored in theequipment database 324. The system 10 can be configured to display othertypes of information in the OR, such as education materials, asdiscussed further below with respect to the education module 228.

Although the illustrated embodiments of FIGS. 12 and 13 each includeonly one display for the system 10 in an OR, any number of displays forthe system 10 can be provided in an OR. Providing a plurality ofdisplays can allow more information to be easily accessible to medicalpersonnel in the OR at any given time, can help focus medical personnelby allowing for different medical personnel to have dedicated displaysproviding information most useful for their particular job, and/or canreduce surgeon fatigue by allowing the surgeon to position themselvesdifferently than if the displays were not available. Additionally, anyone or more displays for the system 10 in the OR can be configured todisplay a plurality of views, e.g., have picture-in-picture capability(e.g., two different camera angles of the same surgical site) and/orprovide overlays of data (e.g., overlaid tissue layers that can bepeeled away one or more at a time to expose underlying layer(s)).

The system 10 can be configured to allow different data displays to beaccessed on demand in the OR, e.g., a data display of a saved simulationplan and/or a comparison of a saved simulation with the actual procedurebeing performed, patient vital sign data, surgical procedure metrics,etc. In an exemplary embodiment, the system 10 can be configured toproject digital keys (e.g., a keypad projected on or near the patientincluding keys) configured to be tapped to change display on the userinterface and/or effect other system controls such as requesting that aspecific medical staff member be paged to the OR, requesting aninstrument from an instrument tray, rewind a simulation shown on adisplay, etc.

FIG. 17A illustrates an embodiment of a projection system configured tofacilitate projection onto an irregular screen surface such as on apatient in the OR or on another irregular surface such as an instrumenttray or a drape. The projection system can include a plurality ofprojectors 136 configured to project an image onto an irregular screensurface 138. Each of the projectors 136 can be configured to be incommunication with a CPU (not shown) of the system 10 so as to beconfigured to transmit information to and receive information from theCPU. The CPU can be in communication with at least one cloud server ofthe system 10 such that the CPU and/or a processor in communication withthe cloud server(s) can perform data processing. Other CPUs discussedherein can be similarly configured to communicate with cloud server(s).Each of the projectors 136 in the illustrated embodiment is identical toone another, although projectors in the system can vary from oneanother. FIG. 17B illustrates one of the projectors 136 in closerdetail. The projector 136 can include an RGB projector 136 a configuredto project RGB images, an IR sensor 136 b configured to sense infraredsignals, and an IR projector (dot and rectangle) 136 c configured toproject infrared images. Using IR can allow the projectors 136 toconstantly align with one another and track the surface 138, which canallow for constant updating and good quality projection. Single viewerperspective tracking the surface 138 can allow for sub-surfaceprojection allusions. The dot projection of the IR projector 136 c canbe used for surface mapping, and the rectangle projection of the IRprojector 136 c can be used for multi-projection overlap seaming. All ofthe projectors 136 can be synchronized to be in rectangle projectionmode at once and then each take a turn in dot mode for surface mapping.The CPU can be configured to control the rectangle and dot modes of theprojectors 136.

In another exemplary embodiment, the system 10 can be configured toallow selective switching between the different displays via no-touchcontrols. In this way, medical personnel can quickly receive datawithout compromising sterility and without having to change theirposition relative to the patient and without having to free their handsfrom instrument(s) and/or other surgical duties. No-touch controls canbe similarly used for other system instructions, e.g., begin projectionof digital keyboard, requesting that a specific medical staff member bepaged to the OR, requesting an instrument from an instrument tray,rewind a simulation shown on a display, etc. Non-limiting examples ofno-touch controls include motion sensing (e.g., swiping a hand in theair mimicking a page turn to cause a next display screen to be displayedon the user interface as if turning a page in a book), eye movementtracking (e.g. looking at a specific location or combination oflocations in the spatial field either alone), voice recognition (e.g.,speaking a certain key term or key phrase to cause a certain display tobe shown on the user interface), and direct brain interface (e.g., viaelectroencephalography (EEG) sensors and event related potential ERPtechniques including but not limited to use of P300, slow corticalresponse, and neural network based training methods). No-touch controlscan also be used in any combination, e.g., looking at a specificlocation in a spatial field room and speaking a specific activationword. A specific activating location in the visual field can be dynamicand part of a computer controlled display device.

FIG. 18 illustrates an embodiment of a motion sensing system configuredto allow no-touch control of the system 10. The motion sensing systemcan include a projector 82 and an infrared (IR) and RGB camera 84configured to gather data related to movement of a person in the OR. Thegathered data can be transmitted to a central processing unit (CPU) 86that is part of the system 10, the CPU 86 being configured to analyzethe received data to determine if display on a user interface, such as adata board 83, should change. The data board 83 can include a flatsurface that can be tracked for position by the camera 84, and can haveselected images displayed on the surface thereof. The user can touch theprojection on the data board 83 of a virtual input device, such as abutton, to which the system can respond as having read the user's fingermotion, position, and projected image as a command. The no-touchcontrols can facilitate communication of orders from a surgeon to ORstaff. In the illustrated embodiment, the CPU 86 can be coupled to alaser pointer 87 configured to communicate orders to OR staff bydirecting OR staff to a specific needed instrument from among aplurality of instruments on a tray 89 by laser pointing to the neededinstrument. The laser pointer 87 can be coupled to a movement mechanism,e.g., a rotation mount 85, configured to move in response toinstructions received from the CPU 86, e.g., instructions to rotate acertain amount in a certain direction to cause the laser pointer 87 topoint to the needed instrument on the tray 89. The laser pointer 87 caninclude a camera (not shown) configured to provide visual confirmationon the user interface that the laser pointer 87 has pointed to theneeded instrument, which can allow the user providing the instruction tovisually confirm the instruction.

FIG. 19 illustrates an embodiment of a direct brain interface system,such as the EPOC Neuroheadset (available from Emotiv Systems of SanFrancisco, Calif.), configured to allow no-touch control of the system10. The direct brain interface system can include a plurality of EEGsensors 88 configured to be position on a head of a user 90, e.g., asurgeon. The EEG sensors 88 can be configured to transmit data to a CPU92 that is part of the system 10, the CPU 92 being configured to analyzethe received data to determine if display on a user interface 94 shouldchange. Additionally or alternatively, the CPU 92 can be configured toanalyze the received data to determine if one or more pieces of ORequipment 96 (e.g., surgical tools, lights, tables, etc.) needadjustment and, if so, to cause such adjustment to occur (e.g., dim alight, turn on a light, zoom in a camera, adjust table height, etc.). ORequipment can be connected to the direct brain interface system by aprogrammable processor, such as an Arduino.

FIG. 20 illustrates an embodiment of a no-touch data communicationsystem configured to provide information hands-free to a user 140 of thesystem 10. The no-touch data communication system can be configured toallow the user 140 to control receipt of information from the system 10through movement. In other words, the system 10 can transmit differentinformation to the user 140 based on the movement of the user 140.Additionally, the no-touch data communication system can be configuredfor single-person use so as to allow the selected information to betransmitted uniquely to the user 140 such that one or more other usersof the system 10 in the OR can have their own no-touch datacommunication system, which can allow each user to select theinformation that would be most helpful for their particular task athand. The no-touch data communication system can, however, be configuredto transmit the same information to a plurality of users based onmovement control of the one user 140. The no-touch data communicationsystem can include a transparent lens head mounted display 142configured to be mounted on a head of the user 140. The transparent lenshead mounted display 142 can be equipped with orientation tracking suchthat when the transparent lens head mounted display 142 is mounted onthe head of the user 140, the user's head movements can control whichinformation is displayed to the user 140. The transparent lens headmounted display 142 can be configured to communicate with a CPU 144 ofthe system 10, thereby allowing the information displayed by thetransparent lens head mounted display 142 to be up to date in real time.In an exemplary embodiment, the motion of the user's head, e.g., turningand/or raising of the head, can allow the user 140 to see different datain different spherical zones 146. Each of the spherical zones 146 candisplay a different type of data, e.g., information regarding ORequipment, pre-op data, patient vital signs, informational feedregarding surgical steps, visualization of the surgical site with tissuelayer(s) overlay, etc. In another embodiment, the motion of the user'shead, e.g., turning and/or raising of the head, can cause the CPU 144 tocause projection of different data onto the patient and/or othersurface.

Plan Tracking Module

The plan tracking module 226 can provide users of the system 10 with aninterface for tracking progress of an actual surgical procedure in asurgical setting, e.g., in an OR. The progress of an actual surgicalprocedure can be tracked against a typical performance of the surgicalprocedure stored in the products and procedures database 320 and/ortracked against a 3D simulated surgery performed via the pre-op module202 and saved in the procedure database 316. The typical performance ofthe surgical procedure can be pre-programmed, e.g., a saveddemonstration version of the surgical procedure performed underlaboratory or test conditions, or the typical performance of thesurgical procedure can be aggregated from previous actual performancesof the surgical procedure tracked by the system 10 and stored in theproducts and procedures database 320. The previous actual performancesof the surgical procedure can be by a specific surgeon (e.g., thesurgeon performing the actual surgical procedure), by surgeons at aspecific hospital (e.g., the same hospital as where the actual surgicalprocedure is being performed), or by surgeons at multiple hospitalsregistered with the system 10. In an exemplary embodiment, the progressof an actual surgical procedure can be tracked against a 3D simulatedsurgery performed via the pre-op module 202 and can be saved in theprocedure database 316 to allow the surgeon performing the procedure tofollow previously-made decisions regarding the surgery, e.g., timing ofthe procedure's steps, medical devices used in the procedure, amount ofpatient tissue to remove, etc., since, as discussed above, the surgeonperforming the actual surgical procedure can electronically simulate thesurgery using the system 10. The system 10 can allow a user to pull up asimulation saved in the procedure database 316, thereby allowing thesimulation to be visible and/or accessible in an OR.

The plan tracking module 226 can be configured to assist with surgicalsetup of a patient and one or more instruments to be used in surgery onthe patient. The plan tracking module 226 can be configured tofacilitate positioning of a patient for surgery. Because a patient'sinner anatomy does not always align with spatial references of anoperating room (or other area in which surgery is performed), andusually does not so align, it can be difficult for surgical staff toalign the patient in a desirable position relative to the surgeon forperformance of a specific surgical procedure. Numerous angles andasymmetries of the patient's inner anatomy, which differ betweendifferent patients, can result in lengthy pre-surgery evaluation of aspecific patient's inner anatomy using techniques such as x-ray,fluoroscopy C-arm, and MRI, lengthy pre-surgery planning for thepatient's position during surgery based on the evaluation, and lengthymanual positioning of the patient in the operating room (or othersurgical area) based on the pre-surgery plan. Hidden anatomicalstructures, such as spinal elements, cannot be easily seen in anorthogonal sense as there are no cornerstones to align or columns totrue. Repeated x-rays, and hence repeated radiation exposure, and/orinvasive dissections are often traditionally needed to establish a frameof reference for a surgical task to use as its substructure duringsurgery. Traditional alignment using a gravity vector reference usingrobotics and image guidance are expensive, time consuming, and requiresteep learning curves and/or specialized user operators. Additionally,although apparatuses exist that can be used by surgical staff to assistin positioning a patient, these apparatuses are traditionallycomplicated and require a high level of user involvement. The plantracking module 226 can be configured to automate patient positioning,which can reduce complexity of patient processing, reduce chances ofsurgical instruments being advanced into a patient at an unsafe and/orundesired trajectory, improve access to a surgical site by optimizing apatient's position, save time over manual patient adjustment, and/orreduce an amount of pre-surgery radiation and/or invasive pre-surgerydissections to determine proper patient positioning. Positioning thepatient using the plan tracking module 226 can thus provide enhancedsafety, enhanced ergonomics, and unfettered patient positioning withenhanced patient comfort, pressure relief, and surgical staff ease ofuse.

For some surgical procedures, such as spinal surgeries in which atrajectory of lateral approach can be very precisely determined so as toaccess a target vertebra while avoiding nerve damage, a patient'sposition can be of particular importance to the surgery's duration andultimate success. During lateral interbody surgery, for non-limitingexample, it can be advantageous to align a representative plane of asuperior endplate of a patient's inferior vertebra to vertical plumb,and it can be advantageous to align a mid frontal plane of the patient'sinterbody space to vertical plumb. In other words, it can beadvantageous to position a center of the patient's vertebral disc, aswell as endplates of the vertebrae, straight down from a perspective ofa surgeon performing the surgery. Implantation of one or morepercutaneous screws while a patient remains in a lateral position is anon-limiting example of a spinal surgical procedure in which precisepatient positioning is important. Lining up a patient's pedicle 160 fordirect horizontal pedicle screw placement can be at about a 30°rotation, as shown in FIGS. 29A and 29B. FIG. 29B shows the pedicle 160in an initial position, e.g., at 30°, on the left, and in a rotatedposition, e.g., at 0° (horizontal), on the right.

The plan tracking module 226 can be configured to match the patient'sposition with a pre-surgery plan, e.g., a plan indicated in a savedsimulated surgery or a plan for a typical procedure of a same type asthe surgery being performed. The matching can be achieved in a varietyof ways, such as through patient mapping/registration and/or throughvideo tutorials. In an exemplary embodiment, the plan tracking module226 can be configured to begin patient positioning assistance with avideo tutorial saved in the products and procedures database 320. Thepatient positioning assistance can continue using positioning/navigationtechnology, e.g., Microsoft Kinect, that can track actual position ofthe patient versus the pre-surgery plan. As the patient is moved, theplan tracking module 226 can be configured to compare the patient'sactual position to images of the patient and to the pre-surgery plan andcan be configured to provide feedback on how to move the patient to theproper position as defined in the pre-op plan. The images of the patientcan include previously gathered images, e.g., fluoroscopy, MRI, or CTimages stored in the diagnosis database 310, and/or images gathered inreal-time with the positioning, e.g., skin surface mapping, fluoroscopy,ultrasound, or intraoperative CT images. The patient can be imagedthroughout the procedure in real time to help ensure that the patient isproperly positioned during the procedure. Because the system 10 can helpthe patient be properly positioned according to surgeon instructions asindicated in the saved simulation, the surgeon need not necessarily bepresent in the OR when the patient is positioned by one or more medicalpersonnel. The positioning time can be tracked by the plan trackingmodule 226 and can be recorded by the product and procedures database320, which can help show improvements in efficiency over time and/orafter additional training of OR staff.

FIG. 21 illustrates an embodiment of a visual position and orientationtracking system configured to gather real time images of a patient in anOR. The illustrated system includes a fluoroscopy system, but as will beappreciated by a person skilled in the art, other visual position andorientation tracking systems can be used. The system can include one ormore augmented reality markers 72 configured to be recognized by an RGB(red, green, and blue) or RGB-D (red, green, and blue plus depth) camera74. The marker(s) 72 can be positioned on and/or near the patient totrack position of the patient and fluoroscopy frame. The camera 74 canbe configured to communicate with a CPU 75 of the system 10, which cancause image(s) gathered by the camera 74 to be displayed on a display73.

The plan tracking module 226 can be configured to continually providefeedback to the one or more medical personnel positioning the patient,such as instruction as to how much to move a patient in a certaindirection and an indication when the patient is in a position matchingthe pre-surgery plan, which can help ensure that the patient is properlypositioned in the OR prior to start of the surgery. Because the system10 can allow electronic tracking and positioning of patients, numerousdifferent patient positions can be accommodated, such as moretraditional recumbent positions and less traditional standing positions.

In another exemplary embodiment, the plan tracking module 226 can beconfigured to facilitate patient positioning using automated bedmovement. A person skilled in the art will appreciate that movement of a“bed” discussed herein includes movement of any operating surface onwhich a patient can be positioned for surgery, such as a table, aplatform, etc., and is not necessarily a traditional bed. The plantracking module 226 can be configured to cause translation and/orrotation of the bed, with the patient thereon, to position the patientin a desired position for surgery. FIG. 30 illustrates an embodiment ofa patient 156 on a bed 158 at desired L2-L3, L3-L4, and L4-L5 angles,shown with arrows, as positioned using the plan tracking module 226. Asshown, the bed 158 can include a plurality of discrete sections eachconfigured to move relative to the other discrete sections, which canallow for more precise positioning of various portions of the patient156 on the bed 158.

The plan tracking module 226 can be configured to cause the bedtranslation and/or rotation in a variety of ways. In an exemplaryembodiment, X-Y-Z axis data for the bed can be transmitted to the system10, and the plan tracking module 226 can be configured to use thereceived X-Y-Z data to determine an amount and direction of movement forthe bed to position the patient thereon in a desired position forsurgery. The X-Y-Z axis data for the bed can be gathered in a variety ofways. For non-limiting example, a plurality of two-dimensional (2D)and/or 3D images can be gathered using one or more types of imaging,e.g., imaging capable of rendering spatial coordinates such asradiograph, ultrasound, commuted tomography, magnetic resonance, etc.,using one or more electromagnetic capture devices. The plan trackingmodule 226 can be configured to process the 2D images and/or the 3Dimages to derive X-Y-Z movement commands for bed positioning. The plantracking module 226 can be configured to process the images in a varietyof ways, such as by establishing a relation between the image data andcoordinates of the bed. The relation can be established in any number ofways, as will be appreciated by a person skilled in the art, such as byusing a calibration frame positioned within the imaging area combinedwith real time measurements of the frame's orientation to a knowncoordinate on the bed's frame and image capture device frame.Additionally, the plan tracking module 226 can be configured to compareimage capture data to previously received data such as a known CT dataset.

A majority of desired coordinates are vector quantities. The vectorquantities, such as planar endplate orientations, midpoints, andtrajectory angles, are independent of scalar calibration. Thus, the plantracking module 226 can be configured to accurately process coordinatedata without accurate unit values within the image frames of referencebecause angles (vectors) do not change based on scale.

As will be appreciated by a person skilled in the art, the plan trackingmodule 226 can determine how to repeatedly and accurately spatiallyposition the bed in a variety of ways, such as by using motion controlprocessing or software. For non-limiting example, for a spinal surgeryusing a trajectory of lateral approach that begins on the L3/L4 spinallevel, the surgeon and/or other surgical staff can input this level tothe plan tracking module 226, e.g., using an input device such as akeyboard in communication with a processor in communication with theplan tracking module 226. The plan tracking module 226 can then analyzean initial image of the patient and initial bed coordinates to cause thebed to be moved so as to position the patient in a desired position forthe surgeon to begin the procedure on the L3/L4 spinal level. Then, ifthe surgeon desired to move to another area of the patient, such as theL4/L5 level, an updated input can reposition the patient in position forthe surgeon to begin the procedure on the L4/L5 spinal level, as patientposition is different for different lateral approaches. The updatedinput can be input to the plan tracking module 226 after the patient hasbeen positioned in the first position, which can allow for the surgeonto make in-surgery decisions as appropriate, or the updated input can beinput at the same time as the first input, which can help save timeafter the patient has been partially operated on and is more vulnerableto surgical complications than prior to being incised. Additionally, insurgery using a lateral approach, it can be advantageous to back uplaterally-performed surgery with posterior instrumentation. If two setsof implants are to be implanted in the patient, a surgeon and/or othersurgical staff traditionally must remove the patient from the lateralposition in which the lateral surgery was performed and reposition thepatient in a prone position in which the posterior surgery can beperformed. Physically repositioning the patient mid-surgery in this waycan be time consuming and can be awkward for surgical staff due tosurgical instrumentation, surgical accessories, etc. on or in thepatient during the repositioning. The plan tracking module 226 can allowfor the patient to be automatically repositioned from the lateralposition to a modified lateral position where posterior instrumentationtrajectories are of a direct horizontal nature, or conversely to amodified prone position where desired trajectories are plumb, therebysaving time and reducing complexity of the surgical procedure. The plantracking module 226 can thus be configured to move the patient to aninitial position for surgery and to move the patient to one or moresubsequent positions during the surgery, thereby allowing for differentaspects of the surgical procedure to be performed on the patient atdifferent angles that are each safe, appropriate, and convenient for theperforming surgeon.

The plan tracking module 226 can be pre-programmed with a desiredpatient position for one or more specific surgical procedures, e.g.,spine procedures such as anterior lumbar interbody fusion (ALIF),extreme lateral interbody fusion (XLIF), etc. The plan tracking module226 can thus be programmed to “know” a desired position for a patientwhen a specific surgical procedure is input to the system 10 by a useras being for the patient. The plan tracking module 226 can thus beconfigured to automatically position the patient in the pre-programmeddesired patient position using real time images of the patientindicating a current position of the patient, which the plan trackingmodule 226 can analyze in spatial coordinates relative to the desiredpatient position to determine an amount of translational and/orrotational movement of the bed to desirably position the patient.

FIGS. 31-33 illustrate an embodiment of pre-surgery images that canfacilitate automatic patient positioning using the plan tracking module226. The images of FIGS. 31-33 are fluoroscopy images, but as discussedabove, other types of images can be obtained to assist with patientpositioning in the OR (or other surgical area). Fluoroscopic images canbe gathered in real time in an OR using a C-arm, as will be appreciatedby a person skilled in the art. Although the images of FIGS. 31-33 arespinal images that can assist in automatic positioning a patient forspinal surgery, the plan tracking module 226 can be configured toanalyze images and automatically position a patient for surgeries onother parts of the body.

FIG. 31 illustrates an embodiment of a baseline image as a fluoro imageof a patient's lumbar spine without an attempt to align the patient on abed in any particular position relative to an operative center. In otherwords, the surgical staff can initially position the patient on the bedin a generally lateral position without careful precision as to thepatient's position because the patient's position will be subsequently,automatically adjusted, unless the unlikely situation occurs where thepatient is accurately initially positioned. The baseline image canfacilitate anatomical recognition by the plan tracking module 226, asdiscussed further below. FIG. 32 illustrates an embodiment of a fluoroimage including anatomical recognition performed by the plan trackingmodule 226 for a first input position. The anatomical recognition inFIG. 32 includes vertebral levels, e.g., L2, L3, etc., and endplateperimeter geometry 154. The endplate perimeter geometry is shown in FIG.32 at the L3/L4 level to reflect an initial level for surgery input tothe plan tracking module 226 as being the L3/L4 level. The plan trackingmodule 226 can also be configured to identify high crest for any of thevertebral levels. The plan tracking module 226 can perform theanatomical recognition in a variety of ways. For non-limiting example,the plan tracking module 226 can compare the baseline image of FIG. 30with pre-stored anatomical data stored in the operation database 304(and/or any other database). The pre-stored anatomical data can be datafor a generic patient, e.g., anatomical textbook data, or can be actualanatomical data aggregated from a plurality of previously gatheredimages of actual patients. The plan tracking module 226 can beconfigured to filter the baseline image to create outlines, which canfacilitate comparison of the baseline image with the pre-storedanatomical data to determine features in the baseline image, e.g., anendplate, a pedicle, etc. For non-limiting example, algorithms toperform such analysis include image guided surgery calibrationalgorithms, such as those discussed in U.S. Pat. No. 7,130,676 entitled“Fluoroscopic Image Guided Orthopaedic Surgery System WithIntraoperative Registration” issued Oct. 31, 2006, and European Pat. No.1028659 entitled “Virtual Representation of a Bone or Bone Joint” issuedFeb. 18, 2004. Based on the pre-stored data in which various anatomicalparts, e.g., levels of vertebra, are pre-identified, the plan trackingmodule 226 can be configured to identify various anatomical parts in thefirst input position. FIG. 33 illustrates an embodiment of a fluoroimage post-positioning, e.g., with the patient having been automaticallymoved to the initial position, e.g., the bed has been translated and/orrotated as discussed above. In the illustrated embodiment, the bed hasbeen moved to position the patient slightly anterior of the disc centerat L3/L4. The post-positioning fluoro image can, as shown in FIG. 33,include the anatomical recognition performed by the plan tracking module226 including the vertebral levels, e.g., L2, L3, etc., and the endplateperimeter geometry 154. The plan tracking module 226 can be configuredto repeatedly adjust the patient's position to arrive at the desiredpatient positioning, with repeated fluoro images being gathered in realtime to assist the plan tracking module 226 in analyzing the patient'sactual position on the bed.

Movement of the bed can be performed in any one or more of the X, Y, andZ dimensions depending on the initial position of the bed and thedesired position of the bed relative to the initial position of the bed.Additionally, the movement can be translational and/or rotational in anyof the X, Y, and Z dimensions.

The bed can be configured to move in a variety of ways. In an exemplaryembodiment, one or more servo motors and one or more positioning sensorscan be coupled to the bed. The plan tracking module 226 can beconfigured to transmit instructions to the servo motor(s) to translateand/or rotate the bed in a certain amount in any one or more of the X,Y, and Z dimensions to align desired targets with vertical plumb orhorizontal level or an angle therebetween, and to place the desiredtargets on center. By adjusting position of the patient by adjustingposition of something on which the patient rests (the bed), the system10 can help reduce chances of accidental patient repositioning duringsurgery because the bed can provide a stable surface on which thepatient rests without straps, slings, supports, etc. holding up part(s)of the patient that could accidentally loosen, shift, or otherwise slipduring surgery. The servo motor(s) can be coupled to one or more jigscoupled to the bed such that actuation of one or more of the motor(s)can cause movement of one or more the jig(s), thereby adjustment analignment of the bed, and hence an alignment of a patient on the bed.The sensor(s) can sense position of the bed and/or the jig(s) andtransmit the sensed data to the system 10, which can analyze the data toensure that the bed, and hence the patient, has been properlypositioned. In an embodiment of spinal surgery, a center of a disc canbe moved directly on target, or a center of a pedicle can be aligned onaxis and with a user input, e.g., a user's push of a key on a keypad incommunication with the system 10, a center of an opposite pedicle.

In another exemplary embodiment, one or more inflatable braces can becoupled to the bed. The brace(s) can be configured to be selectivelyinflated and deflated independent of any other braces coupled to thebed. The brace(s) can be coupled to the bed in locations in which thebrace(s) can interact with a patient on the bed such that inflating anyof the braces can cause movement of the patient. The brace(s) can thusbe configured to facilitate positioning of the patient on the bed.Depending on an amount of inflation/deflation, inflating/deflating thebrace(s) can cause the patient to move different amounts, therebyallowing for relatively precise adjustment of the patient's position onthe bed. Similar to that mentioned above regarding the servo motor, byadjusting position of the patient by adjusting position something onwhich the patient rests (the brace(s)), the system 10 can help reducechances of accidental patient repositioning during surgery because thebed and brace(s) can provide a stable surface on which the patient restswithout straps, slings, supports, etc. holding up part(s) of the patientthat could accidentally loosen, shift, or otherwise slip during surgery.

The brace(s) can have a variety of sizes, shapes, and configurations. Inan exemplary embodiment, the brace(s) can be formed from abiocompatible, flexible, radiolucent material. The brace(s) can becoupled to the bed in any way, such as by being integrally formedtherein, by being included in a slipcover placed over/around the bed, orby being attached to the bed or cover thereon with a securing elementsuch as Velcro or glue. If the brace(s) are configured to be removablyand replaceably coupled to the bed, such as with Velcro, the bed caninclude a diagram or other markings thereon to indicate placement of thebrace(s) thereon. The markings can be generic, e.g., be for any surgicalprocedure, or can be customized for particular surgical procedures,e.g., be color coded with different colors indicating position ofbrace(s) for different surgical procedures. The brace(s) can be inflatedwith any one or more types of fluid. The fluid, in an exemplaryembodiment, is surgically safe such that in the unlikely event of braceleakage, the fluid cannot harm the patient or surgical staff.

The system 10, e.g., the procedure analysis module 230 discussed furtherbelow, can be configured to determine an amount of time it takes toposition the patient, e.g., from the system's start of the videotutorial to the system's determination that the patient's positionmatches the pre-surgery plan. The determined amount of time can be savedin the operation database 304, e.g., in the OR database 322. Inalternative or in addition to determining an amount of time it takes toposition the patient, the system 10, e.g., the personnel tracking module236, can be configured to register (e.g., identify and log) the one ormore medical personnel who help position the patient and to trackmovement of the one or more medical personnel who help position thepatient, as discussed further below. The determined amount of timeand/or the information regarding the medical personnel can be analyzedto develop metrics that can be later viewed and tracked by one or moreusers, such as the surgeon who performed the surgery and administratorsat the hospital where the surgery was performed, to help drive learningand best practices.

Similar to that discussed above regarding facilitating patient position,the plan tracking module 226 can be configured to facilitate positioningof one or more surgical instruments before a surgical procedure begins.Also similar to that discussed above regarding facilitating patientposition, the plan tracking module 226 can be configured to match one ormore instruments' position with a pre-surgery plan (e.g., usingpositioning/navigation technology and/or imaging), and the system 10(e.g., the equipment tracking module 230, discussed further below) canbe configured to determine an amount of time is takes to position eachinstrument, register (e.g., identify and log) the instruments as beingpresent, and/or to track movement of the registered instruments. Theinstrument movement can be tracked and logged as distinct motions, e.g.,insertion and removal of the instrument into the surgical space; actionsof the instruments such as removal of bone, movement of tissue,insertion of material (e.g., a bone screw, interbody cage, biologic,combination treatment, etc.), etc.; etc. The determined amount of timeand/or the information regarding the instruments can be analyzed todevelop metrics that can be later viewed and tracked by one or moreusers, such as the surgeon who performed the surgery and administratorsat the hospital where the surgery was performed, to help drive learningand best practices and/or to determine instrument effectiveness.

The plan tracking module 226 can be configured to provide feedbackregarding a surgical procedure throughout actual performance thesurgical procedure as measured against at least one model, e.g., a savedsimulated procedure and/or a pre-programmed procedure. The feedback canbe provided visually (e.g., on a display device, by lights, etc.), bymotion (e.g., by vibration, etc.) and/or by sound (e.g., by audio beep,etc.). The feedback can include data including a progress of the actualsurgical procedure as measured against the model. The feedback can allowa surgeon and/or other medical personnel involved with the surgicalprocedure to continually validate and confirm that the steps being takenin the surgery line up with a saved pre-op plan and/or with convention.Should the actual procedure deviate from the model within a certain,predetermined degree of tolerance, the plan tracking module 226 can beconfigured to trigger an alert, e.g., a visual, auditory, and/or motionsignal, indicating the deviation. Different alarms can be used by theplan tracking module 226 to indicate different deviations, e.g., a firstsignal for a skipped step, a second signal for an incorrect instrumentbeing used, a third signal for a planned instrument being missing fromthe OR, a fourth signal for not enough tissue and/or bone removed fromthe patient, a fifth signal for too much tissue and/or bone removed fromthe patient, a sixth signal indicating unexpected patient vital sign(s),a seventh signal indicating an instrument has entered an undesirablearea of the anatomy based on the pre-op plan, etc. In an exemplaryembodiment, the plan tracking module 226 can be configured to predictdeviation from the model within a certain, predetermined degree oftolerance and trigger the alert before the surgery has gone too faroff-model or too close to a higher risk or incorrect area of thepatient.

In response to an alert, the system 10 can allow a user, e.g., thesurgeon, to access the surgical procedure planning module 218 to modifythe saved simulation for the surgical procedure. In this way, thesurgeon can prepare a plan on the fly with consideration to unexpectedcircumstances that arise during the procedure and/or to test differentsurgical techniques and/or medical devices prior to actually performingthe techniques and/or actually using the medical devices. The modifiedsimulation can be performed, saved, and later accessed similar to thatdiscussed above.

Procedure Analysis Module

The procedure analysis module 230 can provide users of the system 10with an interface for evaluating progress of the surgical procedure. Keymetrics of progress for payers, providers, and regulators can begathered by the procedure analysis module 230 to facilitate billing andregulatory compliance. Non-limiting examples of progress data that theprocedure analysis module 230 can gather and/or analyze and provide to auser of the system 10 include anatomical information, nerve information,pain information, a running total case time, a total amount of patientblood loss, spinal disc removal information, an amount of bone removedfrom the patient, and an amount of tissue and/or bone removed for graft.The progress data can be selectively displayed on a display device asdiscussed above. The surgical procedure planning module 218 can beconfigured to similarly provide data to a user performing a surgicalsimulation so as to help correct any potential problems before an actualsurgery is even performed.

The provided anatomical information can include information regardingtissue (e.g., soft tissue), bone, nerves, intervertebral disc material,etc. The procedure analysis module 230 can be configured to provideanatomical information in a variety of ways. In an exemplary embodiment,the procedure analysis module 230 can be configured to provide a layeredanatomical visualization on a display device. The anatomicalvisualization can be a generic visualization of a typical patient, orthe anatomical visualization can be specifically based on the patient,similar to that discussed above regarding modeling of the patient forpre-op electronic simulation. The anatomical visualization can show alltissue types (e.g., soft tissue, bone, vessels, nerves) to helpfacilitate navigation around them in actual performance of the surgery.FIG. 22 illustrates one embodiment of an anatomical visualization for aspinal surgery in which a bone layer, a vessel layer, and a nerve layerare displayed, with a soft tissue layer hidden. The different layers canbe selectively hidden and displayed. For surgery in another area of apatient's body, e.g., knee surgery, a different part of a patient can beshown, e.g., a portion of a leg. In some embodiments, the differentlayers can be selectively projected, printed, or overlaid onto thepatient to facilitate identification of the patient's anatomicalstructures to help identify “safe” zones and avoid injury to thepatient.

Using nerves as an example of the procedure analysis module 230providing anatomical information, nerve tractography technologies suchas Diffusion Tensor Imaging (DTI) or MRI with specialized sequences canbe used to determine a 3D shape and location of the nerves byregistering water content. The shape and location of the nerves issensed by MRI unit, which also registers one or more fiducials on thepatient. This image can be loaded into the system 10, allowing the imageto be merged with the 3D anatomical model based on the referencelocation in space provided by the fiducial(s). This fusion can allow thesystem 10 to display the nerves overlaid on the bony anatomy in one orboth of pre-op planning and in the OR. Additional OR sensingtechnologies can help to locate the nerves during surgery, such as anerve sensing or stimulating probe using conventional triggeredEMG ortriggeredMMG technology for nerve localization that can be tracked bythe navigation system in order to generate spatial information about thenerve location in real time as the probe is moved during the procedure.This can accommodate tissue movement associated with patient positioningand operative manipulations. This navigable nerve sensing probe can beconfigured in a grid pattern rather than a single instrument, therebyallowing multiple sensing and stimulating points over the nerve. Thesemultiple sensing and stimulation points can result in determining thedistance to the nerve, and through software analysis and conductiontheory, can reconstruct the size and shape of the nerve. Because thegrid pattern is navigated, its location in space is known, and as aresult the location of the nerve in space is known and can be merged tothe 3D representation of the patient in the OR navigation system,thereby allowing visual navigation around the nerves as well as the bonystructures, even as they are moved along with the muscle tissue orretracted during access.

In one exemplary embodiment, the procedure analysis module 230 can beconfigured to provide visualization of patient anatomy (e.g., bones,nerve roots, vascular structures, etc.) using augmented reality. Theprocedure analysis module 230 can be configured to provide an augmentedreality imaging system that can overlay computer generated imagery ontoone or more physical objects, e.g., a patient, a table, a drape, etc.,that can be visualized by a user, e.g., a surgeon or other surgicalstaff. In an exemplary embodiment, the computer generated imagery can beoverlaid on a patient, which can facilitate identification of variousanatomical structures of the patient, including those structures thatare hidden behind one or more other anatomical structures such thattheir location can be discerned from the imagery without actually beingvisible to the user. The imagery can be overlaid in an surgical setting,e.g., an OR, which can facilitate performance of a surgical procedure byproviding visualization of patient anatomy that would otherwise not bevisible. The surgery can thus be performed with improved accuracy andconfidence because a more complete picture of a patient's anatomy can beprovided in real time with surgery. The procedure analysis module 230can be configured to overlay the imagery in 3D with depth perception,which can provide intuitive visualization of 3D objects that cannot beso visualized using a traditional 2D display device, e.g., a computermonitor, and that are more naturally viewed in 3D. The overlaid imagerycan also be easily viewed by a user from different angles, such as bythe user moving his/her head, walking around, etc. The augmented realityimaging system can allow the surgeon and/or other surgical staff in asurgical setting to focus on the patient rather than on an externaldisplay device.

The procedure analysis module 230 can be configured to provide theaugmented reality imaging system in a variety of ways. In an exemplaryembodiment, the procedure analysis module 230 can be configured toanalyze gathered images of a patient to generate a 3D model of thepatient's anatomy based on the images. The images can include previouslygathered images, e.g., fluoroscopy, MRI, or CT images stored in thediagnosis database 310, and/or images gathered in real-time, e.g.,fluoroscopy, ultrasound, or intraoperative CT images. The generated 3Dmodel can be stored in the system 10, such as in the procedure database316. The procedure analysis module 230 can be configured to register thegenerated 3D model to one or more reference markers mounted on aphysical object, e.g., on a patient in an OR or other surgical setting.The registration can be performed automatically by the procedureanalysis module 230, or the registration can be manually triggered by auser, e.g., via a no touch data communication system similar to thatdiscussed above with respect to FIG. 20. The reference marker(s) can besimilar to the augmented reality markers 72 discussed above withreference to FIG. 21. In an exemplary embodiment, a plurality ofreference markers can be mounted on the patient, such as by adhering themarkers to the patient using a biocompatible adhesive that allowsremoval of the markers from the patient. The procedure analysis module230 can be configured to track the reference marker(s) mounted on thephysical object to determine a correct location to display the generated3D model with respect to the physical object.

A surgeon and/or other surgical staff can wear a stereoscopic viewingdevice, such as a head-mounted stereoscopic viewing device similar tothe head mounted display 142 discussed above with reference to FIG. 20.The stereoscopic viewing device can be a see-through device, or it canbe an opaque display. If the stereoscopic viewing device is an opaquedisplay, the stereoscopic viewing device can include a video cameraconfigured to capture a view in front of the device's wearer so that thewearer isn't “blind.” The procedure analysis module 230 can beconfigured to track the stereoscopic viewing device to help determinewhere to overlay the generated 3D model in a location where it can bevisualized by the wearer of the stereoscopic viewing device. Theprocedure analysis module 230 can be configured to use the stereoscopicviewing device to overlay the generated 3D model on the physical object,e.g., the patient, in an anatomically correct location. In other words,the procedure analysis module 230 can be configured to project thegenerated 3D model of anatomy in a location corresponding to thepatient's actual anatomy. As the wearer of the stereoscopic viewingdevice moves around, the procedure analysis module 230 can be configuredto automatically adjust the generated 3D model in real time so that thegenerated 3D model is always overlaid in the anatomically correctlocation. The wearer can thus use the generated 3D model as a supplementto ordinary visualization (either directly in the case of a transparentviewing device, or with the aid of the video camera in the case of anopaque device) to allow visualization of anatomy that would otherwisenot be visible to the wearer.

The procedure analysis module 230 can be configured to overlayinformation other than anatomical information. The procedure analysismodule 230 can be configured to calculate the additional overlaidinformation based on the patient images previously gathered and/orgathered in real time. The additional overlaid information can include,for non-limiting example, a recommended trajectory for implantimplantation (e.g., a recommended implantation trajectory for a pediclescrew), dimensions of anatomy (e.g., dimensions of pedicles/vertebralbodies), a distance between various anatomical structures (e.g., adistance from one pedicle to an adjacent pedicle), and/or an estimatedposition and orientation of an implanted implant. The dimensions ofanatomy can help a surgeon and/or other surgical staff determine anappropriate size of an implant to use with a patient, such as anappropriate screw size. The distance between various anatomicalstructures can help a surgeon and/or other surgical staff determine anappropriate sized implant to connect multiple anatomic structures, suchas a length of spinal rod to span multiple vertebra. The estimatedposition and orientation of the implanted implant can help a surgeonand/or other surgical staff determine a location of the implant when theimplant is otherwise not visible, e.g., if the implant is radiolucentand not visible in a gathered image of the patient. Methods andapparatuses of estimating the position and orientation of an implant aredescribed in more detail in U.S. application Ser. No. 13/488,827entitled “Methods and Apparatus For Estimating The Position AndOrientation Of An Implant Using A Mobile Device” filed Jun. 5, 2012,which is incorporated by reference in its entirety.

Nerve information provided by the procedure analysis module 230 caninclude information gathered by the procedure analysis module 230regarding, e.g., nerve health, nerve stretch, and pain levels. Theprocedure analysis module 230 can be configured to gather data regardinga time length of tissue retraction, an amount of the tissue retraction,and/or an amount of pressure being placed on tissue and/or nerves as aresult of the retraction. The procedure analysis module 230 can gathersuch information using, e.g., sensors attached to a retractor andmonitoring nerve diameter, RT Automatic Atlas Segmentation (availablefrom Brainlab Corporation of Feldkirchen, Germany), etc. RT AutomaticAtlas Segmentation, for example, can be used in pre-op planning todetermine the pathway through nervous tissue with allowable stretch whencompared to a library of nerve tension and post-op pain levels, e.g., alibrary stored in the procedure database 316, and can be used againduring the surgical procedure to predict tissue movements withoutre-imaging the patient. Final imaging can compare a projected movementof the tissues to actual movement of the tissues, and the system 10 canbe configured to record this relationship in the OR database 322,thereby improving the system's predictive algorithms through continuallearning. If tissue is retracted during surgery for too long, thepatient can feel pain following surgery. The procedure analysis module230 can therefore analyze the gathered data to determine if the tissueretraction should be released and/or readjusted to help avoid futurepatient pain. The procedure analysis module 230 can be configured todetermine that retraction should be released and/or readjusted based ona variety of factors, such as clinical study data, data previouslygathered by the system 10 regarding lengths, locations, and durations ofretraction in previously performed surgical procedures, and/or datapreviously gathered by the system 10 regarding pain levels of patientsfollowing surgeries. The procedure analysis module 230 can be configuredto provides notification of the pain levels to the user during thesurgery. The system 10 can thus be configured to correlate retractionlengths, locations, and durations with patient pain and learn over timeso as to allow the procedure analysis module 230 to determine whentissue has been retracted improperly and/or for too long. In someembodiments, the procedure analysis module 230 can be configured tocause automatic release or readjustment of tissue retraction upondetermination that retraction should be released or readjusted, such aswhen the instrument performing the retraction is coupled to a movementmechanism that can be electronically controlled by the system 10.Similarly, in some embodiments, the procedure analysis module 230 can beconfigured to mechanically prevent a retractor from applying too muchpressure, e.g., through the use of one or more clutches. Instruments canbe provided that can sense tissue segmentation through the use ofultrasound and provide the system 10 with feedback on the instrument'slocation in a desired tissue plane.

Spinal disc removal information gathered, analyzed, and/or provided bythe procedure analysis module 230 can include, e.g., a running totalamount of spinal disc removal and chemical content of disc material. Thechemical content of disc material can be measured by the procedureanalysis module 230 and analyzed to calculate appropriate dosing ofmedication.

FIG. 23 illustrates an embodiment of a void confirmation system of theprocedure analysis module 230 configured to indicate how muchintervertebral disc material has been removed from a patient's spine. Itcan be difficult to see how much disc material has been removed, andwhere it has been removed from. The void confirmation system can allowfor electronic measurement of disc removal and electronic confirmationof where disc material has been removed, thereby providing betterinformation than can typically be gathered by visualization. The voidconfirmation system can include at least one sensor 126 and at least oneemitter 128. The sensor(s) 126 can be, e.g., a spherical IR orultrasonic sensor or a sonar depth sensor. The sensor(s) 126 and theemitter(s) 128 can be introduced into the disc space. The sensor(s) 126can be configured to gather data regarding a volume of unobstructed discspace, and the emitter(s) 128 can be configured to transmit the gathereddata to a CPU 130 of the system 10. The system 10, e.g., the procedureanalysis module 230, can be configured to analyze the received data anddetermine an amount of disc material that has been removed from thepatient based on a comparison of the received data with previouslygathered data, e.g., pre-op image data indicating a geometry of thepatient's disc space. The procedure analysis module 230 can additionallyor alternatively be configured to analyze received data for endplatethickness and/or density variations. The CPU 130 can be configured todisplay results of the analysis on a display 132. Although disc removalis shown in the illustrated embodiment, other material removed from thepatient, such as tissue and bone, can be similarly electronicallyconfirmed.

The OR analysis module 234 can be configured to track placement ofimplant trials (e.g., in pre-op planning) and placement of actualimplants. The position of the implants and trials can be tracked usingany one or more methods, such as navigation systems that use infrared orvisual cameras; electromagnetic, radiofrequency, and microwave sensorsattached to or embedded in the implants or trials (e.g., embeddedsensors available from CardioMEMS, Inc., Atlanta, Ga.); etc. Embeddedsensors can be used after implantation as well, such as tonon-invasively collect data related to bone growth rate, forces actingon the implant, and position of the implant through wireless connectionwith an external interface device. Additionally or alternatively, theembedded sensors can be used to control the implants through via thesystem 10 and/or other external control device. For example, an implantin the form of an adjustable height interbody device can be instructedto increase or decrease its height at multiple segments in order toprovide better balance or contact with the endplate to promote spinalalignment and bone growth.

Education Module

The education module 228 can provide users of the system 10 with aninterface for requesting and/or receiving informational materials duringperformance of a surgical procedure. By providing access toinformational materials in an OR, questions can be quickly answered andthe surgery can proceed with minimal delay and without any medicalpersonnel having to leave the OR to obtain the information.

The informational materials can include video conferencing capabilityand/or educational resources as discussed above regarding the SPP module218, such as materials stored in the catalog database 318. The educationmodule 228 can allow users of the system 10 to access the informationalmaterials in any way, such by using no-touch controls, as discussedabove. The system 10 can be configured to allow access to informationalmaterials regardless of the information displayed on a display device ofthe system 10 at any particular time.

Video conferencing can be available to bring at least one external thirdparty, e.g., a physician, a family member of the patient, technicalstaff, a resident, an expert on a certain aspect of the surgicalprocedure, etc.) into communication with medical personnel in the OR.The system 10 can therefore allow for remote viewing of one or moresurgical procedures being performed, which can help provide training,help hospital administrators with scheduling, and/or help keep familymembers of the patient informed about the surgery. Data regarding thesurgical procedure that can be accessed remotely can be limited based ona type of user accessing the system, e.g., more access for residents,less access for family members, etc. In an exemplary embodiment, aremote access app configured to run on a mobile phone, tablet computer,etc. can be configured to allow family members of the patient toremotely access the system 10 to receive updates regarding progress ofthe surgical procedure, e.g., a timeline or progress report mapping apercentage of progress of the actual surgical procedure against thepre-op plan for the procedure, thereby helping to keep family membersautomatically informed about the surgery's progress regardless ofwhether the family members are located at the hospital or not.Additionally, the app can be available for download to personaldevice(s) and/or available on a device issued temporarily to familymembers at the hospital, thereby allowing family members to access thesystem 10 who may not otherwise have a device at the hospital that isappropriate to access the system 10.

Equipment Tracking Module

The equipment tracking module 232 can provide users of the system 10with an interface for managing equipment used in a surgical procedure.The equipment tracking module 232 can manage equipment by registering,tracking, and ordering equipment.

In an exemplary embodiment, equipment can be registered and trackedthroughout a surgical procedure such that at any given time during theprocedure (including when a patient may not necessarily be present, suchas during setup and clean up), the equipment tracking module 232 can beconfigured to gather data regarding instrument(s) present in the OR andin a sterile configuration. The equipment tracking module 232 cantherefore be configured to help manage efficient use of instruments in asurgical procedure being performed and, through subsequent analysis bythe post-op module 206 of data gathered by the equipment tracking module232, help improve efficiency, lower costs of future surgical procedures,facilitate billing, and maximize reimbursement. The equipment trackingmodule 232 can additionally or alternatively be configured to trackregistered instruments in sterilization, which can help ensure thatcleaning and sterility have been performed before instruments are usedin the OR, help assess quality of sterilization, help reload instrumentstrays more quickly, and help assist in set scheduling based on caserequirements in the pre-op plan for the surgical procedure.

The equipment tracking module 232 can be configured to gather varioustypes of data regarding instruments used in the OR. Non-limitingexamples of data that the equipment tracking module 232 can beconfigured to gather include an identification of which and how manysurgical instruments are present in the OR at any given time, how longeach surgical instrument is in use during the surgical procedure, numberof instrument passes/exchanges, misuse of instruments, loading andacceleration data, instrument damage, amount of power consumed byinstruments, and out of instrument specification conditions. The system10 can be configured to provide instant feedback to the user oninstrument use through a display screen or feedback directly from theinstrument, e.g. light, vibration, etc. Examples of instrument usefeedback include misuse of the instrument, excessive force levels, or adamaged or non-functional instrument.

Equipment can be registered and tracked in a variety of ways, such as byusing one or more optical and/or infrared cameras in the OR. Thecamera(s) can be configured to detect an instrument and compare gathereddata regarding the detected instrument with equipment data stored in theequipment database 324 to register the instrument as a certain type ofinstrument, e.g., a scalpel, a retractor, etc., and/or as a uniqueinstrument, e.g., identification by bar code on the instrument,identification by smart chip or radio frequency identification (RFID)tag embedded in or otherwise attached to the instrument, etc. In thisway, every instrument used in the procedure and/or present in the OR canbe identified, which can facilitate tracking during the procedure andfacilitate use analysis (including non-use) in post-op analysis of theprocedure.

One embodiment of an instrument tracking system can include an augmentedreality tracking system, similar to that discussed above regarding FIG.21. The augmented reality marker(s) 72 configured to be recognized bythe RGB camera 74 can be used to track position and navigation ofinstruments.

FIG. 24 illustrates an embodiment of an instrument tracking systemincluding a magnetic based tracking system 100, such as Razer Hydrahardware available from Razer USA Ltd. of Carlsbad, Calif. The magneticbased tracking system 100 can be configured to communicate with a CPU 98of the system 10, which can cause a data related to gathered trackingdata to be displayed on a display 102, e.g., a list of all instrumentscurrently in use. The magnetic based tracking system 100 can be coupledto at least one camera, e.g., a visual camera or an infrared camera,which can be configured to calibrate a location of the magnetic basedtracking system 100 and use the electromagnetic tracking of the magneticbased tracking system 100 to navigate instrument(s) without requiringline of sight to the instrument from the camera(s). Whether used inconjunction with the magnetic based tracking system 100 or not, thecamera(s) can be configured to record movement of the instrument(s),which can be stored in the equipment database 324 for later analysis,e.g., analysis performed by the post-op surgery feedback module 238discussed further below.

FIG. 25 illustrates an embodiment of a skin surface mapping andinstrument tracking system including a positioning/navigation technologysystem, similar to that discussed above patient positioning assistanceusing positioning/navigation technology such as Microsoft Kinect. Thepositioning/navigation technology system can include one or more markers118 configured to be recognized by one or more IR cameras 116. Themarker(s) 118 can be positioned on and/or near the patient to facilitatetracking motion of an instrument 120 used relative to the patient. Themarker(s) 118 can additionally or alternatively facilitate detection ofa skin surface of the patient, determination of bone locations mapped topre-op image(s) of the patient, and tracking of medical personnel motionand/or posture. The IR camera(s) 116 can be configured to communicatewith a CPU 122 of the system 10, which can cause image(s) gathered bythe camera(s) 116 to be displayed on a display 124. Fluoroscopy can beused for verification. Although only one instrument 120 is shown in theillustrated embodiment, more than one instrument can be trackedsimilarly to the instrument 120.

The equipment tracking module 232 can be configured to anticipate futureinstrument needs during a surgical procedure and trigger an instructionto retrieve the instrument(s) identified as being needed and, ifnecessary, prepare the retrieved instrument(s) for imminent use. Theequipment tracking module 232 can be configured to determine whatinstrument will next be needed based on any number of factors, such ason previously gathered data stored in the procedure database 316 and/orthe products and procedures database 320 regarding previously performedsurgical procedures of a same type as the surgical procedure beingperformed, on the surgical procedure's pre-op plan as indicated in asimulation saved in the procedure database 316, and/or on the flow ofthe surgical procedure performed thus far. The equipment tracking module232 can be configured to identify all next-needed instruments, or theequipment tracking module 232 can be configured to determine whichinstrument(s) are critical to the surgical procedure based on theirfrequency of use in previously performed surgical procedures of a sametype as the surgical procedure being performed and only trigger aninstruction for the critical instrument(s). In an exemplary embodiment,the equipment tracking module 232 can be configured to trigger aninstruction for all next-needed instruments, regardless of their actualor calculated criticality to the procedure.

The triggered instruction can take any number of forms, such as byidentifying an instrument for a medical staff member to retrieve and/orprepare for the surgeon. The identification can be achieved in anynumber of ways, such as by displaying the instrument on a display screenwith a notation that the instrument is needed now or in “X” amount oftime, laser pointing to the instrument on an instrument tray, lightingup the instrument's location on an instrument tray, etc.

In some embodiments, retrieval of instruments can be automated, such asby a robotic scrub tech or vending machine/tool changer configured toprovide each successive instrument. The robotic scrub tech or vendingmachine/tool changer can be configured to pick up each successive neededinstrument, pass the instrument through a sterile field (e.g., flashsterilization, chemical sterilization, etc.), and deliver the sterilizedinstrument to a scrub tech. The robotic scrub tech or vendingmachine/tool changer can thus help reduce instrument sterilization costsbecause only instruments used are sterilized, rather than sterilizing anentire instrument set. The robotic scrub tech or vending machine/toolchanger can be configured to receive a triggered instruction from theequipment tracking module 232 such that only instruments identified asbeing needed as sterilized on as as-needed basis.

As mentioned above, the equipment tracking module 232 can be configuredto verify cleanliness and/or sterilization of instruments in the OR. Inan exemplary embodiment, both cleanliness and sterilization can beverified. The equipment tracking module 232 can be configured to verifycleanliness and sterilization in a variety of ways, such as by using abuilt-in ultraviolet light and an optical camera configured to recognizeinstruments. The equipment tracking module 232 can additionally oralternatively be configured to determine when a non-sterilizedinstrument has breached the sterile field of the OR, e.g., byregistering the instrument and identifying the instrument as not beingnoted in the equipment database 324 as having passed throughsterilization, and if so, to trigger an alert to user(s) of the system10 in the OR. The equipment tracking module 232 can be configured toprovide a warning, e.g., a visual warning on a display, etc., may if asterile instrument has been removed from the sterile field.

As also mentioned above, the equipment tracking module 232 can beconfigured to help reload instruments trays more quickly, since time isoften wasted in refilling trays after cleaning instruments in centralsterilization. The equipment tracking module 232 can facilitate reloadof instruments trays in a variety of ways. FIG. 26 illustrates anexemplary embodiment of an instrument sorting system configured to allowthe equipment tracking module 232 to help reload instruments trays morequickly. The instrument sorting system can include an IR and RGB camera104 configured to gather data regarding an instrument 108 andcommunicate the gathered data to a CPU 106 of the system 10. The CPU106, e.g., the equipment tracking module 232 executed by the CPU 106,can be configured to analyze the received data to identify theinstrument 108 and provide instructions as to which instrument tray 110and where in the instrument tray 110 the instrument 108 should be placed(if placement of the instrument 108 in the tray is relevant, e.g., ifthe instrument 108 is not the only instrument on or to be on the tray110). The CPU 106 can provide the instruction in a variety of ways. Inthe illustrated embodiment, the CPU 106 can be coupled to a laserpointer 112 configured to communicate orders to medical personnel bydirecting medical personnel to the specific tray 110 by laser pointingto the tray 110 and/or a specific location on the tray 110. The laserpointer 112 can be coupled to a movement mechanism, e.g., a rotationmount 114, configured to move in response to instructions received fromthe CPU 106, e.g., instructions to rotate a certain amount in a certaindirection to cause the laser pointer 112 to point to tray 110 and/or aspecific location on the tray 110. The laser pointer 112 can include acamera (not shown) configured to provide visual confirmation on a userinterface that the laser pointer 112 has pointed to the tray 110, whichcan allow a user to visually confirm the instruction. Although only oneinstrument 108 is shown in the illustrated embodiment, the IR and RGBcamera 104 can be configured to gather data regarding a plurality ofinstruments, and the CPU 106 can be configured to analyze data regardingthe plurality of instruments and provide tray instructions regarding theplurality of instruments.

The equipment tracking module 232 can be configured to triggermaintenance/sharpening/lubrication/recalibration/disposal cycles ofinstruments tracked by the equipment tracking module 232. In anexemplary embodiment, when the equipment tracking module 232 registersan instrument is registered as being used in a surgical procedure, theequipment tracking module 232 can cause the scheduling module 222 todetermine whether the instrument needs to undergomaintenance/sharpening/lubrication/recalibration/disposal, e.g., if theinstrument has been used a certain predetermined number of times asindicated by running tally of uses in surgery detected by the system 10,and if so, to schedule themaintenance/sharpening/lubrication/recalibration/disposal. In this way,the equipment tracking module 232 can help ensure that instruments aremaintained in their best possible condition. The equipment trackingmodule 232 can be configured to provide data on instrument use to aproduct manufacturer. Examples of the provided data include number ofinstrument uses, instrument failure, maintenance and calibration cyclesof instruments, and real-time complaint reporting. The equipmenttracking module 232 can be configured to verify that all instruments anddisposables have been removed from the surgical site and are notremaining in the patient.

OR Analysis Module

The OR analysis module 234 can be configured to provide users of thesystem 10 with an interface for gathering ethnographic informationregarding a surgical procedure. The system 10 can thus be configured toanalyze each surgical procedure on the basis of one or more factors suchas instrument use efficiency, personnel efficiency, and patient health,as well as be configured to aggregate data regarding multiple surgicalprocedures so as to learn trends over time. Individual analysis ofsurgical procedures can help predict outcomes of the procedure and/orcan help the surgeon establish best practices and learn from previousexperience on a personal, confidential level as evaluated by the system10 acting as a neutral third party. Aggregated data can help hospitaladministrators develop a cost per hour for OR time, which can allow thehospital to improve efficiency and lower costs.

The OR analysis module 234 can be configured to review data collectedover multiple surgical procedures, and can be configured to group thedata according to one or more factors such as performing surgeon,procedure type, patient demographic, instruments and implants used,duration, etc. The data can include parameters such as anatomic,physiologic, ergonomic, temporal, spatial, and biomechanical parameters.The system 10, e.g., the post-op module 206, can be configured toperform an analysis on the collected data through one or more algorithmsto generate potential new innovations to the surgical procedure, such asa combining of steps, introduction of a new tool from a differentprocedure, adjustment of a physical location of OR staff or equipment,etc. These generated innovations can then be available for review byusers of the system 10, e.g., a user planning a new surgical procedure,and can be integrated into future cases. The system 10 can be configuredto record when the innovation was used and can be configured to trackthe outcomes of these procedures to compare against the outcomes fromsimilar patients/procedures before the innovation was used. The system10 can be configured to determine through comparison how effective theinnovation was, resulting in further learning of the system 10 on howand when to generate the most effective innovations. This analysis canalso help the system 10 determine if it would be beneficial to continuerecommending this innovation to users and eventually include it as astandardized part of the procedure or to remove it due to its lack ofeffectiveness.

The system 10 can be configured to automatically, continually gatherdata throughout every surgical procedure at an OR in which the system 10is set up, e.g., by camera (still image and/or video image), audiorecording, motion sensor, etc., thereby allowing for seamless datagathering largely transparent to medical personnel in the OR. The ORanalysis module 234 can be configured to coordinate this data gathering.The system 10, e.g., the post-op module 206 discussed further below, canthus be configured to automatically generate efficiency reports at auser-set frequency, e.g., for every procedure, for all proceduresperformed in one day at a hospital, for every “X” number of a certaintype of procedure performed, etc., which can facilitate analysis and useof the data gathered by the system 10.

Multiple technologies present in an OR can be integrated with the system10, thereby allowing centralized management and monitoring of multipletechnologies. The technologies can be modular, as mentioned above,thereby allowing scaling of the system 10 to hospitals, clinics, etc. oflargely varying size and resources, and/allowing the varioustechnologies to be upgraded, replaced, and/or maintained withoutrequiring shutdown of the entire system 10. The OR analysis module 234can be configured to provide a user interface allowing selectiveoperation and/or user settings of any one or more of the technologies ata given time, thereby allowing for modular and personalized control ofthe various technologies. Non-limiting examples of technologies that canbe integrated with the system 10 can include neural monitoring outputs,educational information (e.g., surgical technique videos, etc.), imaging(e.g., CT, fluoroscopy, ultrasound, etc.), navigation, neuralmonitoring, lighting, cameras (e.g., endoscope, microscope, feeds fromoutside the OR, etc.), power usage of instruments, energy devices (e.g.,bovie, bipolar, harmonic devices, etc.), powered tools (e.g., burr,drill, etc.), video outputs (e.g., output video to OR screens),projected images, heads-up displays (e.g., in microscope, loupes,glasses, etc.), connection to a hospital network, vital sign monitoring,robotic control (e.g., control of instruments through pre-plannednavigated space such as disc-clearing robots, etc.), remote viewing ofthe system 10, anesthesia, full room decontamination activated aftercase completion and timed by the scheduling module 222, etc. Thetechnologies can be linked virtually through the system 10, e.g.,through a central interface and processor residing in the OR analysismodule 234. The system 10 can be configured to manage and display theinputs and outputs of each technology on a common display and inputdevice, or they can be physically combined into one central unit, whereeach technology physically plugs in to the unit in a rack system orcomes as an integrated part of the system from the manufacturer. Thisphysically integrated unit can allow for simplification of systemsand/or allow for a reduction in the amount of wires and carts in the OR,and can be scaled in the number of technologies present as needed, ortechnologies can be added using plug-and-play technology to meet theneeds of the surgical case or location of the unit. The technologies canbe configured to interface through a standardized operating system ofthe system 10 that can allow seamless compatibility and integration ofnewly developed or applied technologies.

Personnel Tracking Module

The personnel tracking module 236 can provide users of the system 10with an interface for managing and tracking medical personnel involvedin a surgical procedure. As mentioned above, one or more medicalpersonnel present in the OR can be registered and tracked, such as asurgeon, first assistance, scrub tech, and any other surgical staff. Inan exemplary embodiment, the medical personnel can be tracked throughoutthe surgical procedure such that at any given time during the procedure(including when the patient may not necessarily be present, such asduring setup and clean up), the personnel tracking module 236 can beconfigured to gather data regarding medical personnel present in the OR.The personnel tracking module 236 can therefore be configured todetermine which and how many medical personnel are present in the OR atany given time and how long each of the medical personnel are present inthe OR during the surgical procedure. In an exemplary embodiment,medical personnel are registered and tracked by the personnel trackingmodule 236, and surgical instruments are registered and tracked by theequipment tracking module 232, thereby helping to provide a morecomplete picture of the surgical procedure for analysis, which can helpimprove performance of future surgical procedures.

The medical personnel can be registered and tracked in a variety ofways, similar to that discussed above regarding equipment tracking bythe equipment tracking module 232, such as by using one or more ofoptical and/or infrared cameras in the OR, smart clothing monitors,sensors in instruments, motion capture, and body sensors. Non-limitingexamples of types of personnel data that the personnel tracking module236 can be configured to gather include physiological data (e.g., heartrate, eye movement, time to perform each step in a surgical procedure,body temperature (e.g., via infrared measurement, laser measurement,contact sensors, etc.), posture, fatigue, effort/force applied toinstruments (e.g., as indicators of stress), etc.), an identification ofwhich and how many medical personnel are present in the OR at any giventime, how long each medical personnel member is present during thesurgical procedure, number of personnel changes, personnel injury,radiation exposure (e.g., without medical personnel each having to weara radiation monitoring device such as a dosimeter), etc. The personneldata can relate to patient outcome, as analyzed by the post-op module206 discussed further below, so gathering and analyzing personnel datacan help hospitals plan better (e.g., make changes to OR staff, leavemore time between cases, schedule more frequent and/or longer breaks,etc.) and achieve better patient outcomes. The personnel data can alsohelp indicate if particular staff are particularly skilled at a certainsurgical procedure and/or certain aspects of a surgical procedure, whichcan help identify potential training candidates who can instruct othersas to their technique.

The personnel tracking module 236 can be configured to anticipate futurepersonnel needs during a surgical procedure and trigger an instructionto page, call, email, or otherwise request the presence of a specifictype of medical staff member or a specific individual identified asbeing needed in the OR. The personnel tracking module 236 can beconfigured to determine which personnel will next be needed based on anynumber of factors, such as on previously gathered data stored in theprocedure database 316 and/or the products and procedures database 320regarding previously performed surgical procedures of a same type as thesurgical procedure being performed, on the surgical procedure's pre-opplan as indicated in a simulation saved in the procedure database 316,and/or on the flow of the surgical procedure performed thus far. Theinstruction can indicate an estimated amount of time before therequested personnel is needed in the OR. The personnel tracking module236 can thus allow medical personnel to maximize use of their timeoutside the OR by being called to the OR when they are needed. In otherwords, unnecessary wait time outside the OR can be minimized. Unexpectedscenarios arising during the surgery that require additional medicalpersonnel can also be more quickly addressed by the personnel trackingmodule 236 being configured to request additional medical personnel inreal time without anybody currently present in the OR having to leavethe OR or even free their hands or leave their current location in theOR.

The tracking of personnel can be used as a reminder to staff to continueto use standard infection prevention methods. For example, patientinteractions can be monitored such that when moving from one room toanother a reminder (e.g., a blinking light on a wrist band, etc.) canactivate to make the staff aware that hand washing and/or otherappropriate infection prevention methods are suggested.

Similar to that discussed above regarding the equipment tracking module232, the personnel tracking module 236 can be configured to determinewhen a non-sterilized personnel member has breached the sterile field ofthe OR, e.g., by registering the personnel member and identifying theinstrument as not being noted in the ethnography database 326 as havingpassed through sterilization, and if so, to trigger an alert to user(s)of the system 10 in the OR.

The personnel tracking module 236 can communicate with the schedulingmodule 222 to help drive OR personnel flow in multiple ORs and allow forautomatic rescheduling if medical personnel become unavailable due to,e.g., an unexpected duration of a surgical procedure. The personneltracking module 236 can thus also allow for more efficient determinationof when to start prepping patient, transferring them etc. based onpersonnel availability. This can lead to the development of cost perhour of OR time, and/or the tracking of how the efficiencies reduce theOR time and therefore cost. The cost per hour of OR time and theefficiencies can be stored in the OR database 322 and/or the equipmentdatabase 324.

The personnel tracking module 236 can be configured to gather dataregarding registered OR personnel even when the OR personnel are outsidethe OR and are not actively involved in a case. Non-limiting examples of“outside” data that the personnel tracking module 236 can be configuredto gather include nutrition and energy level. Collection of the“outside” data can help the system 10 determine if and how variousfactors affect case outcomes, and make recommendations for personalchanges (e.g., changes in behavior, rest, nutrition, case scheduling,etc.) to improve outcomes. The personnel data can be made available bythe system 10 only to the user about which the personnel data wasgathered, which can help ensure privacy and help ensure that team moraleis not affected, and/or the personnel data can be made available(anonymously or non-anonymously) to users other than the user aboutwhich the personnel data was gathered, which can allow for morebroad-based data trend analysis.

Post-Op Module

The post-op module 206 can generally provide users of the system 10 withan interface for analyzing a performed surgical procedure and managingpatient post-op treatment. More particularly, the post-op module 206 canallow a surgeon to review data gathered and analyzed by the operationmodule 204 regarding surgeries performed by the surgeon, which can helpa surgeon evaluate his/her performance for efficiency, futureimprovements, etc., and/or can help a hospital or other care facilityevaluate surgery logistics such as personnel needs, surgical instrumentinventories, OR use times, etc. The post-op module 206 can also analyzethe data gathered and analyzed by the operation module 204 to helpimprove future recommendations of the diagnosis and treatment module 200regarding effective treatments, and/or help improve futurerecommendations of the pre-op module 202 regarding simulated surgeriesusing instruments and/or personnel similar to previously performedsurgeries. The post-op module 206 can also suggest post-op treatmentoptions for the patient and can manage the patient's post-op treatment.In this way, the post-op module 206 can be configured to assist withpost-op planning and analysis through a continuum from an end of surgeryto the patient's discharge instructions. The post-op module 206 can beconfigured to compares physical, functional, HRQOL, and health economicdata describing an actual outcome to predicted values for each parameterthat were predicted by the pre-op module 202 during planning. Thepost-op module 206 can be configured to detect and analyze any variancesand can be configured to modulate future predictive models using thedetected and analyzed variances.

In one embodiment, the post-op module 206 can be implemented using oneor more web pages which are configured to receive user input and presentinformation to a user. In an exemplary embodiment, both patients andmedical practitioners can access at least a portion of the post-opmodule 206.

The post-op module can be used as an educational tool for potentialpatients with regard to the expectations of post-operative care,post-operative pain, etc.

The post-op module 206 can include a surgery feedback module 238, apost-op treatment module 240, a post-op patient care module 242. Each ofthe modules 238, 240, 242 is discussed further below in turn.

As mentioned above, the post-op module 206 can be configured to readinformation from and write information to the post-op database 306. Thepost-op database 306 can include a treatment plan database 328. Variousones of the post-op module's component modules 238, 240, 242 can beconfigured to access one or more of the treatment plan database 328and/or various other databases, e.g., the diagnosis and treatmentdatabase 300, the pre-op database 302, the operation database 304, andthe recovery database 308. The treatment plan database 328 is discussedfurther below in connection with the post-op module's component modules238, 240, 242.

Surgery Feedback Module

The surgery feedback module 238 can provide users of the system 10 withan interface for analyzing a performed surgical procedure. In anexemplary embodiment, only medical administrators and medical personnelcan access the surgery feedback module 238. Some aspects of the surgeryfeedback module 238, such as video of the surgery or comparison betweenthe actual surgical procedure and a pre-op plan, can be accessible toonly the performing surgeon, which can help prevent damage to teammorale and help protect privacy. The surgery feedback module 238 can,however, be configured to allow the performing surgeon to make aspectsof the surgery feedback module 238 that are accessible to only theperforming surgeon available to one or more other users of the system10, e.g., residents, insurance providers, etc., which can helpfacilitate training and/or billing.

Various types of data gathered and/or analyzed by the system 10 duringand before a surgical procedure can be displayed on a user interfaceand/or otherwise made available to users of the system 10. FIG. 27illustrates an embodiment of a user interface 148 showing various typesof data related to a previously performed surgical procedure. The userinterface 148 shows three images of a surgical site captured at a sametime from three different perspectives provided by the navigationsoftware with actual post-op images of the implant placement. Anotherportion of the user interface 148 (top right quadrant) shows a patientx-ray of the surgical site. By allowing the user to view different dataand to compare the pre-op planned placement with the actual post-opresult simultaneously, the user can better evaluate success of thesurgical procedure, including compliance of the surgery with the pre-opplan.

Different types of data can be displayed to a user other than theinformation shown on the user interface 148, such as time durations ofcertain steps of the surgical procedure, a total time duration of thesurgical procedure, information gathered by the equipment trackingmodule 232 regarding equipment used in the surgical procedure,information gathered by the personnel tracking module 236 regardingpersonnel involved with the surgical procedure, a saved pre-opsimulation, still or moving image data of all or a portion of thesurgical procedure captured by the procedure analysis module 230, tissueremoval data gathered by the procedure analysis module 230, pre-opimages of the patient stored in the diagnosis database 310, thepatient's pre-op treatment compliance stored in the treatment database312, etc. The surgery feedback module 238 can thus allow each user toevaluate performed surgical procedures in a way most informative anduseful for that particular user.

For non-limiting example, a hospital administrator may be concerned withpersonnel issues to help plan future scheduling of personnel for futuresurgeries, so the hospital administrator may request that the surgeryfeedback module 238 provide personnel data gathered during the surgicalprocedure by the personnel tracking module 236 but not other datagathered by the operation module 204 during the surgical procedure. Thehospital administrator may thus be able to determine various personnelissues from the performed surgical procedure and/or from a plurality ofperformed surgical procedures, such as which types of medical personnelmay be redundant in a certain type of surgical procedure, which types ofmedical personnel should be scheduled at certain times for certainsurgeries, whether any particular medical staff member is involved withover “X” number of failures, etc.

For another non-limiting example, the performing surgeon may be mostconcerned with tracking of the actual surgical procedure against thepre-op plan and may thus request a report from the surgery feedbackmodule 238 indicating deviations of the actual surgical procedureagainst the pre-op plan. The deviations can be presented as percentagecompliance with respect to factors such as goal outcomes, timedifferences, differences in surgical instruments used, differences inangles of trajectory, differences in patient blood loss, measuresagainst validated procedures (e.g., measures against defined steps thathave been shown over time to be effective surgical steps through thecontinual analysis of patient outcomes proving the superior efficacy andsafety of these defined steps), etc., so the surgeon can make decisionssuch as possible changes to make in future surgical procedures, requestsfor additional educational materials to be available for future surgicalprocedures, issues to address in the patient's post-op treatment, notesfor possible follow-up surgery, etc.

For another non-limiting example, an insurance administrator may beconcerned with a surgeon's compliance with validated procedures and/orspecific measures such as reduced re-operations or lower infection ratesbecause the more a surgeon follows validated procedures and complieswith specific measures over time, the lower the surgeon's insurancerates could become because the surgeon has been proven to followvalidated procedures and complied measures. Similarly, the insuranceadministrator may be concerned with a surgeon's success rate because thehigher a surgeon's success rate, the lower the surgeon's insurance ratescould become because the surgeon has been proven to perform effectivesurgeries. The insurance administrator may therefore request, e.g., ameasures against validated procedures report from the surgery feedbackmodule 238 for review by the insurance administrator and/or an insurancecarrier. The measures against validated procedures report can becustomized by user selection to be over a certain period of time for acertain surgeon and/or a certain type of surgery, to include the last“X” number of surgeries performed by a particular surgeon or group ofsurgeons at a particular hospital, etc.

The surgery feedback module 238 can be configured to generate one ormore post-op reports summarizing the surgery performed. The report canbe a brief, one page or less report showing a snapshot of the surgery,which can help quickly inform and/or remind medical practitioners of thesurgery performed on a patient and/or help a patient accurately describethe surgery to third parties, such as their PCP, family members, andairport security (who may need, e.g., precise information regardingimplants in the patient or medication prescribed to the patient). Eachpost-op report generated can be targeted to a particular user, such asthe performing surgeon, the patient's PCP, or the patient. A post-opreport generated for a medical practitioner such as the performingsurgeon or the patient's PCP can include medically precise informationregarding the surgery and/or the patient, such as the type of surgeryperformed, the medical devices implanted in the patient, date of thesurgery, the medications administered to the patient, projected successrate of the surgery based on historic success rates of the surgery andthe patient's particular surgery, etc. A post-op report generated for apatient can include information that is less medically precise than on areport for a medical practitioner, such as the medical devices implantedin the patient, date of the surgery, type of procedure performed, listof medications administered during the procedure, a total time length ofthe procedure, a projected reimbursement by the patient's insurance,name of and contact information for the performing surgeon, name of andcontact information for the hospital or other facility at which thesurgery was performed, etc. Post surgical results and metrics stored inthe operation database 304 and/or in the recovery database 308, such aslength of stay, infection rate, fusion rate, blood loss, etc., can betracked by the hospital and/or surgeon and can be used to drive patientawareness around quality of care and/or used with payers to help supportreimbursement negotiations.

Any of the modules discussed herein can be configured to generate areport similar to the post-op report summarizing the data gatheredand/or analyzed by the particular module, which can help keep medicalpractitioners and patients informed throughout the patient's care.

Post-Op Patient Care Module

The post-op patient care module 242 can provide users of the system 10with an interface for managing and analyzing a patient's in-hospitalpost-surgery care. The post-op patient care module 242 can be configuredto provide one or more one or more recommended post-op care optionsbased on the efficacy of the surgery as analyzed by the surgery feedbackmodule 238 and/or as indicated by manual input from the performingsurgeon and/or other user of the system 10. None, some, or all of therecommended post-op care options can be followed, but by providing afull range of post-op care options, the post-op patient care module 242can help prevent any post-op care decisions from being overlooked orunder-appreciated for a particular patient. Non-limiting examples ofpost-op care options can include medication types and frequencies ofdosage, length of post-op hospital stay, appropriate hospital unit forpatient stay post-surgery, appropriate diet for post-op hospital stay,frequency of vital sign measurements, and post-op imaging (x-rays, CTscan, etc).

The post-op patient care module 242 can be configured to determinepost-op care options in a variety of ways. Similar to that discussedabove regarding the treatment options module 212 and the treatmentdatabase 312, the post-op patient care module 242 can be configured tocompare pre-op and op data for a particular patient with post-op careoptions stored in the treatment plan database 328 and determine which ofthe plurality of possible post-op care options are associated with thepatient's diagnosis (as stored in the diagnosis database 310), thepatient's demographics (as stored in the diagnosis database 310), thepatient's current level of radiation exposure, the patient's careprovider (as not all care options may be available at the patient'scurrent location, so transfer of the patient may be appropriate as partof the patient's post-op care), the type of surgery performed on thepatient (as stored in the treatment database 312 and/or the products andprocedures database 320), and/or the surgery's effectiveness (as storedin the treatment database 312 and/or the products and proceduresdatabase 320). The post-op patient care module 242 can be configured tocause a display screen to show a list of the possible post-op careoption(s). The possible post-op care option(s) can be provided to theuser with a caution that the possible post-op care option(s) arepreliminary only and that the user should consider the patient'scircumstances in determining a post-op care plan. The possible post-opcare option(s) can be provided to the user with historic success ratesof each of the possible post-op care option(s). The historic successrates can be stored in the treatment plan database 328 for each of thepost-op care options and can be manually entered. Alternatively or inaddition, the historic success rates can be based on data collected bythe system 10 regarding a plurality of patients such that the system 10can act as a feedback loop system in which previously collected dataregarding post-op care treatments received by actual patients can informpost-op care options for future patients. The possible post-op careoption(s) can be provided to the user with educational resources for atleast one of the options, e.g., links to informational web pages storedin the system 10 (e.g., in the treatment plan database 328), links tothird party educational websites, lists of or links to journal articlesor books, links to medical device product brochures (e.g., brochuresstored electronically in the system 10), etc.

In some embodiments, the post-op patient care module 242 can providecoding and reimbursement information for each of the suggest post-opcare options. Providing such information can facilitate educateddecision-making about which of the post-op care options to pursue (ifany).

By suggesting post-op care option(s) to a user, the post-op patient caremodule 242 can allow the user to receive and analyze information thatmay be outside their area of medical expertise. The post-op patient caremodule 242 can allow the user to become quickly informed aboutunfamiliar aspects of the patient's case (e.g., a specific abnormalsurgical outcome or with a particular new medication) by recommendingparticular post-op care options to address unfamiliar as well asfamiliar aspects of the patient's case, which can facilitate swift,effective treatment of the patient and/or facilitate education of theuser and the user's colleagues to which the user may discuss theunfamiliarities.

Post-Op Treatment Planning Module

The post-op treatment planning module 240 can provide users of thesystem 10 with an interface for receiving one or more post-op treatmentplan options based on the post-op care of the patient and on theefficacy of the surgery as analyzed by the surgery feedback module 238and/or as indicated by manual input from the performing surgeon and/orother user of the system 10. None, some, or all of the recommendedpost-op treatment plan options can be followed, but by providing a fullrange of post-op treatment plan options, the post-op treatment planningmodule 240 can help prevent any post-op treatment decisions from beingoverlooked or under-appreciated for a particular patient. Non-limitingexamples of post-op treatment plan options can include medication typesand frequencies of dosage, type and duration of physical therapy, typeand duration of occupational therapy, at-home exercise types andfrequency, appropriate timing of follow-up doctor visits, andappropriate at-home diet.

The post-op treatment planning module 240 can be configured to determinepost-op treatment plan options in a variety of ways. In an exemplaryembodiment, the treatment plan database 328 can include a plurality ofpossible post-op treatment options, each of the possible post-optreatment options being associated with at least one possible diagnosis.This post-op treatment options data can be organized in any way, such asin a table. Similar to that discussed above regarding the treatmentoptions module 212 and the treatment database 312, and the post-oppatient care module 242, the post-op treatment planning module 240 canbe configured to compare pre-op data, op data, and post-op care data fora particular patient with post-op treatment options stored in thetreatment plan database 328 and determine which of the plurality ofpossible post-op treatment options are associated with the patient'sdiagnosis (as stored in the diagnosis database 310), the patient'sdemographics (as stored in the diagnosis database 310), the patient'scurrent level of radiation exposure, the patient's care provider (as notall care options may be available from the patient's doctor), thepatient's post-op care, the type of surgery performed on the patient (asstored in the treatment database 312 and/or the products and proceduresdatabase 320), and/or the surgery's effectiveness (as stored in thetreatment database 312 and/or the products and procedures database 320).

The post-op treatment planning module 240 can be configured to cause adisplay screen to show a list of the possible post-op treatmentoption(s). The possible post-op treatment option(s) can be provided tothe user with a caution that the possible post-op treatment option(s)are preliminary only and that a user should consider the patient'scircumstances in determining a post-op treatment plan. The possiblepost-op treatment option(s) can be provided to the user with historicsuccess rates and/or with projected outcome scenarios of each of thepossible post-op treatment option(s). The historic success rates can bestored in the treatment plan database 328 for each of the post-optreatment options and can be manually entered. Alternatively or inaddition, the historic success rates can be based on data collected bythe system 10 regarding a plurality of patients such that the system 10can act as a feedback loop system in which previously collected dataregarding post-op treatments received by actual patients can informpost-op treatment options suggested to future patients. The possiblepost-op treatment option(s) can be provided to the user with educationalresources for at least one of the options, e.g., links to informationalweb pages stored in the system 10 (e.g., in the treatment plan database328), links to third party educational websites, lists of or links tojournal articles or books, links to medical device product brochures(e.g., brochures stored electronically in the system 10), etc. Theprojected outcome scenarios can be based on one or more factors, such ashistoric outcomes, the patient's demographics, the patient's lifestyle,the patient's compliance with pre-surgery treatment as gathered by thetreatment compliance module 216 and stored in the treatment database312, etc.

In some embodiments, the post-op treatment planning module 240 canprovide coding and reimbursement information for each of the suggestpost-op treatment options. Providing such information can facilitateeducated decision-making about which of the post-op treatment options topursue (if any).

The possible treatment options suggested by the post-op treatmentplanning module 240 can include non-surgical treatment options (e.g.,diet adjustments, exercise regimens, medications, etc.) and surgicaltreatment options (e.g., specific surgical procedures). In an exemplaryembodiment, only non-surgical treatment(s) can be initially suggested toa user of the system 10. In this way, a conservative treatment can bepursued before a more radical, typically more costly treatment such asfollow-up surgery is pursued. If one or more of the non-surgicaltreatments are pursued and are determined to unsatisfactorily address apatient's problem(s), then the post-op treatment planning module 240 canbe configured to suggest one or more surgical treatment options. Thepost-op treatment planning module 240 can be configured to suggest theone or more surgical treatment options upon request by a user, e.g.,when a medical practitioner requests non-conservative treatment optionsfor a particular patient, and/or can be configured to suggest the one ormore surgical treatment options when a trigger event occurs, e.g., aftera predetermined threshold amount of time passes from commencement of anon-surgical treatment for a patient after which the patient has notshown a predetermined amount of improvement. By way of non-limitingexample, the post-op treatment planning module 240 can be configured toanalyze data gathered by the recovery module 208, discussed furtherbelow, and determine whether the patient's mobility has improved by acertain degree after a certain amount of time as indicated by reportedpain levels and/or analysis of captured images. Before the post-optreatment planning module 240 suggests one or more surgical treatmentoptions following determination that a non-surgical treatment is notachieving a desired outcome, the post-op treatment planning module 240can be configured to first suggest one or more other non-surgicaltreatments.

By suggesting treatment option(s) to a user, the post-op treatmentplanning module 240 can allow the user to receive and analyzeinformation that may be outside their area of medical expertise, similarto that discussed above regarding the treatment options module 212 andthe post-op patient care module 242.

Recovery Module

The recovery module 208 can generally provide users of the system 10with an interface for managing and evaluating a patient's recovery fromsurgery. More particularly, the recovery module 208 can allow a patientto monitor and manage their post-surgery recovery, such as to recordpersonal data (e.g. pain levels, mobility, time to return to work,compliance with medication, compliance with physical therapy, etc.) andcompare their recovery progress against their personal targets and/oragainst others having similar demographics to the patient. The recoverymodule 208 can also allow medical professionals to review data gatheredand analyzed by the recovery module 208 regarding the patient'spost-surgery recovery, which can help the medical professionals monitorthe patient's progress and provide the patient with updated and/orrevised recovery planning tools and/or recovery activities to help thepatient maximize recovery potential. The recovery module 208 can alsoanalyze the data gathered regarding the patient's recovery from surgeryto help improve future recommendations of the post-op module 206regarding effective recovery options for patients having similardemographics to the patient.

In one embodiment, the recovery module 208 can be implemented using oneor more web pages which are configured to receive user input and presentinformation to a user. In an exemplary embodiment, both patients andmedical practitioners can access at least a portion of the recoverymodule 208.

The recovery module 208 can include a patient monitoring module 244 anda efficacy analysis module 246. Each of the modules 244, 246 isdiscussed further below in turn.

As mentioned above, the recovery module 208 can be configured to readinformation from and write information to the recovery database 308. Therecovery database 308 can include a patient targets database 330 and asurgery targets database 332. Various ones of the post-op module'scomponent modules 244, 246 can be configured to access one or more ofthe patient targets database 330, the surgery targets database 332,and/or various other databases, e.g., the diagnosis and treatmentdatabase 300, the pre-op database 302, the operation database 304, andthe post-op database 306. The patient targets database 330 and thesurgery targets database 332 are discussed further below in connectionwith the recovery module's component modules 244, 246.

Patient Monitoring Module

The patient monitoring module 244 can provide users of the system 10with an interface for monitoring and managing their post-surgeryrecovery. Similar to the treatment compliance module 216, the patientmonitoring module 244 can provide users of the system 10 with aninterface for tracking patient compliance with a post-op treatment plan.The post-op treatment plan can be one of the suggested treatment optionssuggested by the post-op treatment plan module 240, can be one of thesuggested treatment options suggested by the post-op treatment planmodule 240 as modified by a medical practitioner, or can be a treatmentplan entered into the system 10 by a medical practitioner withoutassistance of the post-op treatment plan module 240. The post-optreatment plan can be stored in the treatment plan database 328. Thepatient monitoring module 244 can thus allow monitoring and managementof a patient's post-op treatment, which can help the patient's doctorevaluate the patient's progress and/or can help determine whether andwhen modifications to the post-op treatment plan may be necessary,either adjustment of the post-op treatment plan (e.g., changing dietaryrequirements, changing a frequency of doctor check-ups, etc.) orreplacement of the post-op treatment plan (e.g., a non-surgicaltreatment) with another treatment plan (e.g., a surgical treatment).

Patients and users other than patients can submit data to the patientmonitoring module 244 for storage in the treatment plan database 328.Data can therefore be received by the patient monitoring module 244whether the patient is in or not in a medical setting and can bereceived throughout the patient's post-op treatment and not just whenthe patient visits or consults a medical practitioner. More accurate andmore timely data regarding post-op treatment plan compliance cantherefore be gathered and analyzed. Users can submit data to the patientmonitoring module 244 similar to that discussed above regardingsubmission of data to the diagnosis module 210 and to the treatmentcompliance module 216.

Data can be provided to the patient monitoring module 244 actively bythe patient and/or other users entering the data manually, or data canbe provided passively, e.g., through the use of sensors or devicesautonomously collecting data defined as a part of the post-op treatmentplan. Examples of devices and sensors used to collect the passive datainclude smartphone or tablet integrated devices (e.g., cameras,gyroscopes, accelerometers, global positioning systems, etc.), skinpatches (such as patches available from MC10 Inc., etc.), smart clothingwith integrated sensors, and implants with integrated sensors (e.g.,integrated sensors available from CardioMEMS, Inc.). Examples of thepassive data include range of motion, movement tracking, posture, painlevels, bone fusion measures, medication consumption, heart rate, pulse,sleep patterns, etc.

The application and location of material applied or delivered to thepatient can be tracked by the patient monitoring module 244. Forexample, the intraoperative location of an implant, e.g., a spinalinterbody fusion implant, can be recorded and compared to data recordedpost-operatively or at follow-up visit(s) to determine if the implant istrending to be move or migrating to an undesirable position. Prior tocatastrophic outcomes, the patient's rehabilitation regime can bere-directed and/or a revision surgery can be performed. Additionally, animplant can be configured to be adjusted from outside the patientwithout re-operation through, e.g., radi signals and the use of rareearth magnets built into the implant, which can allow implant height orlordosis to be adjusted in order to compensate for movement of theimplant or subsidence. The expansion of the implant can help to restorelordosis, balance, or decompression, for example.

Also similar to that discussed above regarding the treatment compliancemodule 216, the patient monitoring module 244 can be configured toanalyze received compliance data to determine a compliance level and/ora success rate of the treatment overall and/or per symptom, can beconfigured to compare received post-op treatment compliance data for apatient with historic compliance data for other patients who underwentsimilar post-op treatment to help determine the effectiveness of thetreatment for the patient, and can be configured to receive datasubmitted by patients and users other than patients for storage in thetreatment plan database 328. Users can submit data to the patientmonitoring module 244 similar to that discussed above regardingsubmission of data to the diagnosis module 210 and the treatmentcompliance module 216. The analysis and/or comparison performed by thepatient monitoring module 244 can consider data regarding the patient'sspecific post-op recovery targets as stored in the patient targetsdatabase 330, and/or can consider data regarding post-op recoverytargets for typical patients having received a same type of surgery asthe patient as stored in the surgery targets database 332.

The patient monitoring module 244 can be configured to provide a userwith information regarding a patient's post-op treatment plan, such asby displaying post-op treatment plan information on a device incommunication with the system 10. Non-limiting examples of post-optreatment plan information that can be displayed on the device includereminders for upcoming post-op appointments (e.g., physical therapyappointments), reminders of days/times to take medication, percentage ofoverall compliance with the post-op treatment plan, reminders to uploaddata (e.g., video of exercise, blood pressure and/or other vital signreading, etc.), current list of symptoms and/or pain levels, etc.

FIG. 28 illustrates an embodiment of post-op treatment plan display to auser 150 on a display device 152 in communication with the system 10.Although the display device 152 is a touch screen tablet in theillustrated embodiment, the system 10 can communicate with otherdevices, as discussed above. Similarly, although the post-op treatmentplan displayed on the display device 152 in the illustrated embodimentincludes a calendar indicating days to take medication and a graphindicating overall compliance with the post-op treatment plan, anycombination of different types of information can be shown on a displaydevice in communication with the system 10. The displayed informationcan be customized by a user so that the user can receive the mostrelevant information for their particular post-op treatment plan.Providing feedback on a post-op treatment plan to a patient undertakingthe plan can help encourage the patient's compliance with the planbecause progress can be continually, visibly observed, and becausehealing and resumption of normal activity can be shown as an obtainablegoal.

Efficacy Analysis Module

The efficacy analysis module 246 can provide users of the system 10 withan interface for reviewing data gathered and analyzed by the recoverymodule 208 regarding the patient's post-surgery recovery. Similar tothat discussed above regarding the treatment compliance module 216, thepatient monitoring module 244 can be configured to continually analyzereceived data to help determine the efficacy of a particular patient'spost-op treatment plan in achieving the desired functional outcome,and/or to help monitor the patient's general health. This monitoring canbe performed actively or passively methods, similar to that discussedabove. The patient monitoring module 244 can thus determine that aparticular patient's post-op treatment plan should be modified based oncomparison of the effectiveness of the treatment plan in helping thepatient reach their interim or final recovery targets set by theirsurgeon and/or when compared to the aggregate of other patients' datahaving similarities in multiple factors as determined by the system 10for a high correlation factor, such as procedure type, patient age, bonedensity, spinal levels treated, etc. The patient monitoring module 244can learn from other patients' experiences that the present patient'spost-op treatment could benefit from a modification, e.g., perform aspecific exercise once every other day instead of once daily, ceaseperformance of a particular exercise, decrease salt intake, wear a kneebrace 24/7 instead of only while sleeping, add or change medication typeand dosage, etc. Thus, the predicted outcome of rehabilitation andtreatment can be predicted for the patient if they continue therapiesthat historical patients have followed. This can increase patientcompliance to rehabilitation therapies if the patient can compare theirperformance to others that have had the same procedure and similarrehabilitation therapy. The patient monitoring module 244 can beconfigured to suggest the modification of the patient's treatmentpost-op plan to the patient's care provider, e.g., by providing an alertto the care provider indicating that modification of the patient'spost-op treatment plan is recommended. The care provider can review themodification and determine whether to modify the patient's treatmentplan. Alternatively, the patient monitoring module 244 can be configuredto automatically modify the patient's post-op treatment plan and informthe patient via an alert as to the modified post-op treatment plan.Usually, however, a care provider would review a modification to checkits appropriateness for the particular patient before the patientmonitoring module 244 automatically modifies the patient's post-optreatment plan and informs the patient of the change. Data regardingefficacy of the patient's post-op treatment plan can be stored in thepatient targets database 330. The care provider can compare treatmentgroups and redirect rehabilitation plans to those that have beendetermined to be most effective.

The efficacy analysis module 246 can be configured to capture the datacollected in the operation module 204, the diagnosis and treatmentmodule 200, and the operation module 204 in order to generate acomprehensive data set for each patient. The efficacy analysis module246 can be configured to aggregate these data sets with other patientdata sets. The data collected can be of high enough value such that whenthe data is combined using a sufficient quantity of patients, the resultis a study that could be published in a peer-reviewed medical journalfor the purpose of sharing the outcomes of a certain procedure ortreatment type with a selected patient group. The efficacy analysismodule 246 can be configured to analyze the collected data to determinevariables that may enhance or reduce patient compliance, with insightsused to modify patient compliance with one or more compliance enhancerssuch as reward programs and patient support communities.

System Use

As mentioned above, the systems and methods of using the systemsdescribed herein can be used through a medical treatment continuum ofpatient care. In an exemplary embodiment, the system can be providedthroughout an entirety of the treatment continuum of patient care,thereby maximizing opportunities for data collected during variousportions of the continuum to be used in informing determinations made inany one or more other portions of the continuum. The system can,however, be provided for only a partial portion of the continuum. Thesystem can be flexibly implemented using any one or more modules thereofin any combination. The system can thus be configured to accommodatedifferent monetary cost constraints, different availabilities ofcomputer infrastructure, and different end user needs. For example, onlya diagnosis and treatment module of the system can be provided tofacilitate diagnosing patients and determining treatments for thepatients based on the diagnoses. For another example, only pre-op andpost-op modules of the system can be provided to facilitate the planningand performance of surgical procedures.

FIGS. 34A-42B illustrate exemplary embodiments of using the system 10 invarious portions of the medical treatment continuum. Although themethods are illustrated with respect to the system 10 of FIG. 2, any ofthe systems disclosed herein can be similarly used. Also, althoughvarious ones of the methods are illustrated with respect to a spinalsurgical procedure, the systems disclosed herein can be used withrespect to any type of surgical procedure, as discussed above.

FIGS. 34A-34B illustrate an exemplary embodiment of a use of thediagnosis and treatment module 200, and in particular the diagnosismodule 210. FIG. 35 illustrates another exemplary embodiment of a use ofthe diagnosis and treatment module 200, and in particular the treatmentoptions module 212. FIG. 36 illustrates another exemplary embodiment ofa use of the diagnosis and treatment module 200, and in particular thetreatment compliance module 216. FIG. 37 illustrates another exemplaryembodiment of a use of the diagnosis and treatment module 200, and inparticular the treatment compliance module 216. FIG. 38 illustrates anexemplary embodiment of a use of the pre-op module 202, and inparticular the surgical procedure planning module 218. FIGS. 39A-39Cillustrate another exemplary embodiment of a use of the pre-op module202, and in particular the surgical procedure planning module 218. FIG.40 illustrates another exemplary embodiment of a use of the pre-opmodule 202, and in particular the scheduling module 222 and the patientpreparation module 224. FIGS. 41A-41C illustrate an exemplary embodimentof a use of the operation module 204, and in particular the procedureanalysis module 230. FIGS. 42A-42B illustrate another exemplaryembodiment of a use of the operation module 204, and in particular theequipment tracking module 232 and the personnel tracking module 236.

Conclusion

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical method, comprising: wearing astereoscopic viewing device during performance of a surgical procedureon a patient; receiving from the stereoscopic viewing device avisualization overlaid on the patient indicating a recommendedtrajectory for a pedicle screw into a vertebra of the patient, therecommended trajectory being part of a pre-operative plan for thesurgical procedure developed before the performance of the surgicalprocedure; and receiving an alert indicating a deviation between therecommended trajectory and an actual trajectory of the pedicle screwinto the vertebra of the patient.
 2. The method of claim 1, wherein thevisualization automatically changes during the performance of thesurgical procedure based on a position of a wearer of the stereoscopicviewing device relative to the patient.
 3. The method of claim 2,wherein a processor of a surgical planning, support, and managementsystem causes the automatic changing of the visualization using apre-stored scanned image of the patient.
 4. The method of claim 1,wherein the visualization is three-dimensional.
 5. The method of claim1, wherein the visualization overlaid on the patient also shows nervesof the patient.
 6. The method of claim 1, wherein the visualization alsoindicates at least one of a dimension of the vertebra of the patient, adistance between the vertebra and a second vertebra of the patient, andan estimated position and orientation of an implant implanted in thepatient.
 7. The method of claim 1, wherein a reference marker ispositioned on the patient having the surgical procedure performedthereon, and a location of the visualization overlaid on the patient isbased on a position of a wearer of the stereoscopic viewing devicerelative to the reference marker.
 8. The method of claim 1, wherein thealert includes at least one of a visual signal, an auditory signal, anda motion signal.
 9. The method of claim 1, wherein the deviationincludes an angular difference between a recommended line of approach tothe vertebra and an actual line of approach to the vertebra during thesurgical procedure.
 10. The method of claim 1, wherein the stereoscopicviewing device receives the recommended trajectory over a network from aprocessor of a surgical planning, support, and management system, theprocessor is in communication with a memory of the surgical planning,support, and management system, the memory has the recommendedtrajectory stored therein as part of the pre-operative plan.
 11. Themethod of claim 10, wherein the processor determines the deviation andprovides the deviation to the stereoscopic viewing device over thenetwork.
 12. A surgical system, comprising: a stereoscopic viewingdevice configured to be worn by a user during performance of a surgicalprocedure on a patient and configured to provide to the user athree-dimensional visualization overlaid on the patient indicating arecommended trajectory for a pedicle screw into a vertebra of thepatient; and a surgical planning, support, and management systemincluding a memory and a processor, the memory having stored therein apre-operative plan that includes the recommended trajectory for thepedicle screw into the vertebra of the patient, the memory having storedtherein a pre-operative scanned image of the patient, the processorbeing configured to cause the user during performance of the surgicalprocedure to receive an alert indicating a deviation between therecommended trajectory and an actual trajectory of the pedicle screwinto the vertebra of the patient, and the processor being configured tocause the visualization to automatically change during the performanceof the surgical procedure using the stored pre-operative scanned imageof the patient.
 13. The system of claim 12, wherein the processor isconfigured to cause the visualization to automatically change during theperformance of the surgical procedure based on a position of the userrelative to the patient.
 14. The system of claim 12, wherein thevisualization also indicates at least one of nerves of the patient, adimension of the vertebra of the patient, a distance between thevertebra and a second vertebra of the patient, and an estimated positionand orientation of an implant implanted in the patient.
 15. The systemof claim 12, further comprising a reference marker configured topositioned on the patient having the surgical procedure performedthereon, and the processor is configured to use a position of the userrelative to the reference marker in determining a location of thevisualization overlaid on the patient on.
 16. The system of claim 12,wherein the alert includes at least one of a visual signal, an auditorysignal, and a motion signal.
 17. The system of claim 12, wherein thedeviation includes an angular difference between a recommended line ofapproach to the vertebra and an actual line of approach to the vertebraduring the surgical procedure.
 18. The system of claim 12, wherein thestereoscopic viewing device is configured to receive the recommendedtrajectory and the deviation over a network from the processor.